NEW JERSEY ADMINISTRATIVE CODE TITLE 13 LAW AND

STATE BOARD OF PHARMACY LAW AND PUBLIC SAFETY

Chapter 39 Page 1 of 205 Last Revision Date: 5/20/2024

N EW J ERSEY A DMINISTRATIVE C ODE

T ITLE 13

L AW AND P UBLIC S AFETY

C HAPTER 39

S TATE B OARD OF P HARMACY

STATE BOARD OF PHARMACY LAW AND PUBLIC SAFETY

Chapter 39 Page 2 of 205 Last Revision Date: 5/20/2024

CHAPTER TABLE OF CONTENTS

SUBCHAPTER 1. GENERAL PROVISIONS .................................................................................. 9

13:39-1.1 Purpose and scope........................................................................................................................ 9

13:39-1.2 Definitions..................................................................................................................................... 9

13:39-1.3 Fee schedule ............................................................................................................................... 12

13:39-1.4 Payment of penalties .................................................................................................................. 15

13:39-1.5 Opportunity to be heard............................................................................................................. 15

13:39-1.6 Waiver ......................................................................................................................................... 16

13:39-1.7 Failure to complete application process .................................................................................... 16

13:39-1.8 Compliance with policy and procedures .................................................................................... 16

13:39-1.9 Continuous quality improvement program ................................................................................ 16

SUBCHAPTER 2. REQUIREMENTS FOR INITIAL LICENSURE ..................................................... 18

13:39-2.1 Requirements for initial licensure as a pharmacist .................................................................... 18

13:39-2.2 Licensure examination scores..................................................................................................... 20

13:39-2.3 Proof of character ....................................................................................................................... 20

13:39-2.4 Criminal history background check ............................................................................................ 21

13:39-2.5 Refusal to license ........................................................................................................................ 21

13:39-2.6 Internship and externship practical experience requirements .................................................. 21

13:39-2.7 Pharmacy intern registration requirements ............................................................................... 23

13:39-2.8 (Reserved) ................................................................................................................................... 25

13:39-2.9 (Reserved) ................................................................................................................................... 25

13:39-2.10 (Reserved) ................................................................................................................................. 25

13:39-2.11 (Reserved) ................................................................................................................................. 25

13:39-2.12 (Reserved) ................................................................................................................................. 25

13:39-2.13 (Reserved) .................................................................................................................................

13:39-2.14 (Reserved) ................................................................................................................................. 25

13:39-2.15 (Reserved) ................................................................................................................................. 25

13:39-2.16 (Reserved) ................................................................................................................................. 25

13:39-2.17 (Reserved) ................................................................................................................................. 25

13:39-2.18 (Reserved) ................................................................................................................................. 25

13:39-2.19 (Reserved) ................................................................................................................................. 25

13:39-2.20 (Reserved) ................................................................................................................................. 25

SUBCHAPTER 2A. REQUIREMENTS FOR RECIPROCAL LICENSURE .......................................... 25

13:39-2A.1 Requirements for reciprocal licensure ..................................................................................... 25

13:39-2A.2 Proof of character .................................................................................................................... 28

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13:39-2A.3 Refusal to license ...................................................................................................................... 28

13:39-2A.4 Criminal history background check .......................................................................................... 28

13:39-2A.5 Multistate Pharmacy Jurisprudence Examination.................................................................... 29

SUBCHAPTER 3. PHARMACIST REQUIREMENTS .................................................................... 29

13:39-3.1 Authorization to practice; display of license .............................................................................. 29

13:39-3.2 Replacement license ................................................................................................................... 29

13:39-3.3 Change of name .......................................................................................................................... 29

13:39-3.4 Change of address of record; service of process ........................................................................ 30

13:39-3.5 Verification of licensure .............................................................................................................. 30

13:39-3.6 Reproduction of license prohibited ............................................................................................ 30

13:39-3.7 License renewal .......................................................................................................................... 30

13:39-3.8 License reactivation .................................................................................................................... 31

13:39-3.9 License reinstatement from administrative and disciplinary license suspensions .................... 33

13:39-3.10 Steering prohibited ................................................................................................................... 35

13:39-3.11 Responsibilities of pharmacists ................................................................................................ 35

SUBCHAPTER 3A. CONTINUING EDUCATION ........................................................................ 35

13:39-3A.1 Continuing education credit hour requirements ..................................................................... 35

13:39-3A.2 Criteria for continuing education credit ................................................................................... 36

13:39-3A.3 Continuing education credit hour calculations ........................................................................ 36

13:39-3A.4 Continuing education credit hour reporting procedure .......................................................... 37

13:39-3A.5 Waiver of continuing education requirements ........................................................................ 38

13:39-3A.6 Responsibilities of continuing education sponsors .................................................................. 39

13:39-3A.7 Monitoring of continuing education programs or courses ...................................................... 40

SUBCHAPTER 4. PHARMACY PERMIT REQUIREMENTS .......................................................... 41

13:39-4.1 New pharmacies; pharmacy departments; eligibility and application ....................................... 41

13:39-4.2 Issuance of permits; permit renewals ........................................................................................

13:39-4.3 Display of permits ....................................................................................................................... 42

13:39-4.4 Death of owner or partner ......................................................................................................... 43

13:39-4.5 Change of ownership; asset acquisition ..................................................................................... 43

13:39-4.6 (Reserved) ................................................................................................................................... 44

13:39-4.7 Change of location and/or address of licensed premises .......................................................... 44

13:39-4.8 Remodeling of licensed premises ............................................................................................... 44

13:39-4.9 Change of name .......................................................................................................................... 45

13:39-4.10 Discontinued pharmacies ......................................................................................................... 45

13:39-4.11 Availability of records upon termination of business or change of ownership ....................... 46

13:39-4.12 Business hours; unauthorized closing ...................................................................................... 46

13:39-4.13 Replacement permit ................................................................................................................. 47

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13:39-4.14 Reproduction of permits .......................................................................................................... 47

13:39-4.15 Security of pharmacies and pharmacy departments ............................................................... 47

13:39-4.16 Permits; specialized permits ..................................................................................................... 50

13:39-4.17 Steering prohibited ................................................................................................................... 50

13:39-4.18 Responsibilities of permit holders ............................................................................................ 50

13:39-4.19 Procedures for centralized prescription handling .................................................................... 50

13:39-4.20 Out-of-State pharmacy registration ......................................................................................... 54

13:39-4.21 Procedures for authorized prescriber ordered or government sponsored immunizations

performed by pharmacists, pharmacy interns, or pharmacy externs ........................................................ 57

13:39-4.21A Requirements for pharmacists, pharmacy interns, and pharmacy externs to administer

influenza vaccine to patients under 18 years of age .................................................................................. 63

SUBCHAPTER 4A. REmote processing of prescriptions .......................................................... 64

13:39-4A.1 DEFINITIONS ............................................................................................................................. 64

13:39-4A.2 Remote processing of prescriptions by a new jersey pharmacy .............................................. 64

13:39-4A.3 Remote processing of prescriptions by out-of-state pharmacy ............................................... 69

SUBCHAPTER 5. RETAIL FACILITY REQUIREMENTS ................................................................ 70

13:39-5.1 Purpose and scope...................................................................................................................... 70

13:39-5.2 Pharmacy access and egress....................................................................................................... 70

13:39-5.3 Pharmacy signs ........................................................................................................................... 70

13:39-5.4 Spatial requirement of pharmacy prescription area .................................................................. 71

13:39-5.5 Prescription counter ................................................................................................................... 71

13:39-5.6 Prescription area sink ................................................................................................................. 71

13:39-5.7 Adequate storage ....................................................................................................................... 71

13:39-5.8 Minimum equipment and supplies; cleanliness ......................................................................... 72

13:39-5.9 Prescription balances, scales, weights and automatic counting device ..................................... 74

13:39-5.10 Restriction on storage of prescription legend drugs and controlled dangerous substances ... 74

13:39-5.11 Control and monitoring of temperature of prescription drugs and chemicals ........................

13:39-5.12 (Reserved) ................................................................................................................................. 77

13:39-5.13 Prescription drug retail price list .............................................................................................. 77

SUBCHAPTER 6. PHARMACIST-IN-CHARGE; PHARMACY PERSONNEL .................................... 77

13:39-6.1 Purpose and scope...................................................................................................................... 77

13:39-6.2 Pharmacist-in-charge .................................................................................................................. 77

13:39-6.3 Identification tag......................................................................................................................... 79

13:39-6.4 Meal or restroom breaks ............................................................................................................ 79

13:39-6.5 Prescription handling by pharmacy externs, pharmacy interns, pharmacy technicians,

pharmacy technician applicants, or unlicensed or unregistered personnel............................................... 80

13:39-6.6 Pharmacy technician registration and pharmacy technician applicants .................................... 81

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13:39-6.7 Authorization to practice as a pharmacy technician; display of registration ............................. 83

13:39-6.8 Replacement of technician registration ..................................................................................... 83

13:39-6.9 Technician change of name ........................................................................................................ 83

13:39-6.10 Technician change of address of record; service of process .................................................... 84

13:39-6.11 Verification of technician registration ...................................................................................... 84

13:39-6.12 Reproduction of technician registration prohibited ................................................................. 84

13:39-6.13 Pharmacy technician registration renewal ............................................................................... 84

13:39-6.14 Pharmacy technician registration reactivation ........................................................................ 85

13:39-6.14A Pharmacy technician registration reinstatement from administrative and disciplinary

suspensions ................................................................................................................................................. 86

13:39-6.15 Pharmacy technician duties and pharmacist-technician ratios................................................ 88

SUBCHAPTER 7. DRUG DISPENSING AND PRESCRIPTION RECORDS ....................................... 92

13:39-7.1 Valid prescriptions ...................................................................................................................... 92

13:39-7.2 Lack of information on original prescription .............................................................................. 93

13:39-7.3 Authorization for renewal of prescriptions; new prescriptions ................................................. 93

13:39-7.4 Emergency dispensing ................................................................................................................ 94

13:39-7.5 Approval of FDA necessary ......................................................................................................... 94

13:39-7.6 Required records and documents .............................................................................................. 95

13:39-7.7 Copies of prescriptions and/or patient profile ........................................................................... 96

13:39-7.8 Transfer of prescriptions between pharmacies .......................................................................... 96

13:39-7.9 Filing and storage of controlled substance prescriptions ........................................................... 98

13:39-7.10 Prescriptions transmitted by facsimile ..................................................................................... 98

13:39-7.11 Electronically transmitted prescriptions ................................................................................ 100

13:39-7.12 Labeling ................................................................................................................................... 102

13:39-7.13 Professional judgment in dispensing drugs ............................................................................ 104

13:39-7.14 Advertising and sale of prescription drugs .............................................................................

104

13:39-7.15 Restriction on sale of Schedule V over-the-counter controlled substances .......................... 105

13:39-7.16 Return of prescription medication ......................................................................................... 106

13:39-7.17 Disposal of unwanted drugs ................................................................................................... 107

13:39-7.18 Outdated drugs or drugs marked "sample" ........................................................................... 107

13:39-7.19 Patient profile record system ................................................................................................. 108

13:39-7.20 Drug utilization review ........................................................................................................... 109

13:39-7.21 Patient counseling .................................................................................................................. 110

13:39-7.22 Accurate processing and dispensing ...................................................................................... 111

13:39-7.23 Biological products ................................................................................................................. 111

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SUBCHAPTER 8. (RESERVED) .............................................................................................. 112

SUBCHAPTER 9. PHARMACEUTICAL SERVICES FOR HEALTH CARE FACILITIES ....................... 113

13:39-9.1 Purpose and scope.................................................................................................................... 113

13:39-9.2 Definitions................................................................................................................................. 113

13:39-9.3 Licensure of institutional pharmacies ...................................................................................... 114

13:39-9.4 Contract pharmaceutical services; institutional permit required ............................................ 115

13:39-9.5 Advisory committees ................................................................................................................ 115

13:39-9.6 Pharmacy and Therapeutics Committee; applicability; policies and procedures .................... 115

13:39-9.7 (Reserved) ................................................................................................................................. 115

13:39-9.8 Control of health care pharmaceutical services; responsibilities of the pharmacist-in-charge of

the provider pharmacy ............................................................................................................................. 115

13:39-9.9 (Reserved) ................................................................................................................................. 116

13:39-9.10 Pharmaceuticals; drug supply; investigational drugs; controlled dangerous substances ...... 116

13:39-9.11 Drug disbursement; written orders ........................................................................................ 117

13:39-9.12 Drug disbursement; oral orders ............................................................................................. 117

13:39-9.13 Monitoring of patient drug therapy ....................................................................................... 118

13:39-9.14 Medication not dispensed in finished form ........................................................................... 118

13:39-9.15 Drug labeling ........................................................................................................................... 118

13:39-9.16 Use of patient's own medication ............................................................................................ 118

13:39-9.17 Drug-dispensing devices ......................................................................................................... 119

13:39-9.18 Disposal of unused medications ............................................................................................. 120

13:39-9.19 Records and reports ............................................................................................................... 120

13:39-9.20 Drug information and education ............................................................................................ 122

13:39-9.21 After hours access to the institutional pharmacy .................................................................. 122

13:39-9.22 Pharmacy facilities; space ....................................................................................................... 123

13:39-9.23 Storage and security ...............................................................................................................

124

13:39-9.24 Equipment .............................................................................................................................. 125

13:39-9.25 Institutional decentralized pharmacies .................................................................................. 125

13:39-9.26 Valid medication orders; out-of-State medication orders ..................................................... 125

13:39-9.27 Prescriptions and medication orders transmitted by technological devices in an institution

.................................................................................................................................................................. 126

SUBCHAPTER 10. AUTOMATED MEDICATION SYSTEMS ...................................................... 127

13:39-10.1 Purpose and scope.................................................................................................................. 127

13:39-10.2 "Automated medication system" definition ........................................................................... 127

13:39-10.3 Authority to use automated medication system .................................................................... 127

13:39-10.4 Written policies and procedures of operation ....................................................................... 128

13:39-10.5 Personnel training requirements ............................................................................................ 130

13:39-10.6 Written program for quality assurance .................................................................................. 130

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13:39-10.7 Written plan for recovery ....................................................................................................... 130

13:39-10.8 Written program for preventative maintenance of automated medication system ............. 131

SUBCHAPTER 11. COMPOUNDING STERILE PREPARATIONS IN RETAIL AND INSTITUTIONAL

PHARMACIES ..................................................................................................................... 131

13:39-11.1 Purpose and scope.................................................................................................................. 131

13:39-11.2 Definitions............................................................................................................................... 131

13:39-11.3 Application and pre-approval requirements for compounding sterile preparations............. 135

13:39-11.4 Cleanroom: use, access, location; temperature; air pressure ................................................ 136

13:39-11.5 Cleanroom requirements ....................................................................................................... 137

13:39-11.6 Ante area requirements ......................................................................................................... 138

13:39-11.7 Buffer area requirements ....................................................................................................... 139

13:39-11.8 Use of compounding aseptic isolators and compounding aseptic containment isolators

located outside of a cleanroom ................................................................................................................ 140

13:39-11.9 (RESERVED) ............................................................................................................................. 140

13:39-11.10 institutional pharmacy use of airflow workbenches not in a buffer area for low-risk level

compounded sterile preparations ............................................................................................................ 140

13:39-11.11 Compounding immediate use compounded sterile preparations in an institutional pharmacy

.................................................................................................................................................................. 141

13:39-11.12 Pharmacist-in-charge responsibilities .................................................................................. 141

13:39-11.13 Pharmacy technicians, pharmacy interns, and pharmacy externs; required supervision ... 143

13:39-11.14 Personnel cleansing and garbing requirements ................................................................... 143

13:39-11.15 Cleaning and disinfection requirements for cleanroom, buffer area, and ante area .......... 145

13:39-11.16 Training and evaluation requirements ................................................................................. 145

13:39-11.17 Batch preparation ................................................................................................................. 146

13:39-11.18 Compounded sterile preparations for prescriber practice use ............................................ 147

13:39-11.19 Stability and sterility criteria and beyond-use dating........................................................... 147

13:39-11.20 Documentation; audit trail ................................................................................................... 149

13:39-11.21 Information required to appear on prescription label ......................................................... 150

13:39-11.22 Handling, packaging, and delivery ........................................................................................

151

13:39-11.23 Policy and procedures manual ............................................................................................. 151

13:39-11.24 Quality assurance program .................................................................................................. 153

13:39-11.25 Prohibited compounding ...................................................................................................... 156

13:39-11.26 (Reserved) ............................................................................................................................. 156

13:29-11.27 (Reserved) ............................................................................................................................. 156

SUBCHAPTER 11A. COMPOUNDING NON-STERILE PREPARATIONS IN RETAIL AND

INSTITUTIONAL PHARMACIES ............................................................................................ 156

13:39-11A.1 Purpose and scope ............................................................................................................... 156

13:39-11A.2 Definitions ............................................................................................................................ 157

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13:39-11A.3 Prohibited compounding ...................................................................................................... 157

13:39-11A.4 Compounding commercially available products .................................................................. 157

13:39-11A.5 Batch preparation ................................................................................................................ 158

13:39-11A.6 Compounded non-sterile preparations for prescriber practice use .................................... 158

13:39-11A.7 Preparation of pharmacy generated products (PGPs) for over-the-counter sale................ 158

13:39-11A.8 Compounding area ............................................................................................................... 159

13:39-11A.9 Equipment and supplies ....................................................................................................... 160

13:39-11A.10 Responsibilities of the compounding pharmacist; reporting requirement ....................... 160

13:39-11A.11 Beyond-use dates ............................................................................................................... 162

13:39-11A.12 Ingredient selection............................................................................................................ 163

13:39-11A.13 Information required to appear on prescription label ....................................................... 163

13:39-11A.14 Pharmacy technicians, pharmacy interns, and pharmacy externs; required supervision . 164

13:39-11A.15 Audit trail; compounding record documentation .............................................................. 164

SUBCHAPTER 11B. COMPOUNDING ANTINEOPLASTIC AGENTS AND OTHER HAZARDOUS

SUBSTANCES: STERILE AND NON-STERILE PREPARATIONS .................................................. 165

13:39-11B.1 Purpose and scope ............................................................................................................... 165

13:39-11B.2 Definitions ............................................................................................................................ 166

13:39-11B.3 Compounding antineoplastic agents and other hazardous products: sterile preparations 166

13:39-11B.4 Compounding antineoplastic agents and other hazardous products: non-sterile

preparations .............................................................................................................................................. 168

SUBCHAPTER 12. NUCLEAR PHARMACIES .......................................................................... 169

13:39-12.1 Definitions............................................................................................................................... 169

13:39-12.2 General requirements for pharmacies providing radiopharmaceutical service .................... 170

13:39-12.3 General requirements for a nuclear pharmacist .................................................................... 173

13:39-12.4 Minimum requirements for space, equipment, supplies, and library .................................... 174

13:39-12.5 Quality control ........................................................................................................................ 175

SUBCHAPTER 13. COLLABORATIVE PRACTICE ..................................................................... 175

13:39-13.1 Purpose and scope.................................................................................................................. 175

13:39-13.2 Definitions............................................................................................................................... 175

13:39-13.3 Board approval; pharmacist qualifications; continuing education ........................................ 176

13:39-13.4 Collaborative practice agreement .......................................................................................... 177

13:39-13.5 Collaborative practice protocols............................................................................................. 178

13:39-13.6 Informed consent for collaborative drug therapy management ........................................... 179

13:39-13.7 Scope of collaborative drug therapy management ................................................................ 180

13:39-13.8 Voluntary participation ........................................................................................................... 180

13:39-13.9 Failure to comply .................................................................................................................... 181

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Appendix Collaborative Practice Agreement ...................................................................... 181

SUBCHAPTER 14. SELF-ADMINISTERED HORMONAL CONTRACEPTIVES ............................... 183

13:39-14.1 Protocol for pharmacists furnishing self-administered hormonal contraceptives ................ 183

13:39-14.2 Authorization of pharmacists to furnish self-administered hormonal contraceptives .......... 184

13:39-14.3 Hormonal contraceptives authorized pursuant to the Protocol ............................................ 184

13:39-14.4 Procedures for hormonal contraceptive screening and selection ......................................... 185

13:39-14.5 Procedures for patient counseling and furnishing hormonal contraceptives ........................ 186

13:39-14.6 Recordkeeping ........................................................................................................................ 189

13:39-14.7 Hormonal contraceptive training ........................................................................................... 190

Appendix A Pharmacist Hormonal Contraceptives Protocol ................................................ 191

Appendix B Algorithm for Self-administered Hormonal Contraceptive Pills, Patches, and Rings

......................................................................................................................................... 200

Appendix C Algorithm for Self-administered Injectable Hormonal Contraceptives .............. 202

Appendix D Pharmacist Visit Summary and Referral Template ........................................... 204

SUBCHAPTER 1.

GENERAL PROVISIONS

13:39-1.1 PURPOSE AND SCOPE

a) This chapter is promulgated by the New Jersey State Board of Pharmacy. The rules

contained in this chapter implement the provisions of the New Jersey Pharmacy Practice

Act, N.J.S.A. 45:14-40 et seq., and regulate the practice of pharmacy within the State of

New Jersey.

b) This chapter shall apply to all pharmacies; pharmacists; applicants for permits, licensure

or registration; interns; externs; pharmacy technicians; and anyone within the jurisdiction

of the Board of Pharmacy.

13:39-1.2 DEFINITIONS

The following words and terms when used in this chapter shall have the following meanings,

unless the context clearly indicates otherwise.

"Address of record" means an address designated by a licensee or registrant, which is part

of the public record and may be disclosed upon request. "Address of record" may be a licensee's

or registrant's home, business or mailing address, but shall not be a post office box, unless the

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licensee or registrant also provides another address which includes a street, city, state and zip

code.

“Biological product” means a “biological product” as defined in subsection (i) of section 351

of the Public Health Service Act (42 U.S.C. § 262(i)), and refers to a virus, therapeutic serum,

toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein other

than a chemically synthesized polypeptide, or analogous product, or arsphenamine or any

derivative of arsphenamine or any other trivalent organic arsenic compound, applicable to the

prevention, treatment, or cure of a disease or condition of human beings.

"Board" means the New Jersey State Board of Pharmacy.

"Compounding" means the preparation, mixing, assembling, packaging and labeling of a

drug or device as the result of a practitioner's prescription or initiative based on the relationship

of the practitioner or patient with the pharmacist in the course of professional practice or for the

purpose of, or incident to, research, teaching or chemical analysis and not for sale or

dispensing. Compounding also includes the preparation of drugs or devices in anticipation of

prescription drug orders based on routine, regularly observed prescribing patterns.

"Device" means an instrument, apparatus, implement, machine, contrivance, implant, in vitro

reagent or other similar or related article, including any component part or accessory, which is

required under Federal or State law to be prescribed by an authorized prescriber and dispensed

by a pharmacist, in the usual scope of pharmacy practice.

"Dispense or dispensing" means the procedure entailing the interpretation of a practitioner's

prescription or medication order for a drug, biological or device, and, pursuant to that order, the

proper selection, measuring, compounding, labeling and packaging in a proper container for the

subsequent administration to, or use by, a patient. The act of dispensing shall include all

necessary consultation by the pharmacist.

"Drug or medication" means:

Articles recognized in the official United States Pharmacopoeia/National Formulary,

official Homeopathic Pharmacopoeia of the United States, or any official supplement to

any of them;

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Articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of

disease in human beings or animals;

Articles (other than food) intended to affect the structure of any function of the body of

human beings or animals; and

Articles intended for use as components of any article specified in 1, 2 or 3 above, but not

including devices or their components, parts or accessories.

"Immediate personal supervision" means that the pharmacist is physically present in the

compounding/dispensing area when interns, externs and pharmacy technicians are performing

delegated duties, and the pharmacist conducts any necessary in-process checks and the final

check in preparation and compounding of medications, including the checking of each ingredient

used, the quantity of each ingredient whether weighed, measured or counted, the finished label

and the accuracy and appropriateness of the actions of pharmacy technicians, interns and

externs.

“Interchangeable” means “interchangeable” as defined in subsection (i) of section 351 of the

Public Health Service Act (42 U.S.C. § 262(i)) and indicated as interchangeable by the Federal

Food and Drug Administration in the “Lists of Licensed Biological Products with Reference

Product Exclusivity and Biosimilarity or Interchangeability Evaluations,” sometimes referred to as

the “Purple Book.”

"Legend drug or device" means any drug or device that:

Bears, at a minimum, the symbol "Rx only" or words of similar import; and/or

c) Requires a prescription or order by a practitioner.

"Pharmaceutical services" means all patient-oriented services provided by a pharmacist or

other pharmacy personnel specific to their scope of practice. These services shall be concerned

with, but not limited to: interpreting the prescription or medication order; selecting, preparing,

compounding, packaging, labeling, distributing and dispensing prescribed drugs; the proper and

safe storage of drugs; the monitoring of drug therapy; the reporting and recording of adverse

drug reactions and the provision of appropriate drug information; and teaching and counseling

on the proper and safe use of drugs and medications.

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"Pharmacist" means an individual holding an active license to engage in the practice of

pharmacy in this State.

"Pharmacy" means a location permitted by the Board to engage in the practice of pharmacy

in this State.

“Pharmacy extern” or “extern” means a “pharmacy extern” as defined at N.J.A.C. 13:39-

2.6(a).

“Pharmacy intern” or “intern” means a “pharmacy intern” as defined at N.J.A.C. 13:39-2.6(a).

"Pharmacy technician" means an individual registered with the Board and who works under

the immediate personal supervision of a pharmacist in compliance with N.J.A.C. 13:39-6.15. For

purposes of this definition, interns, externs, cashiers, stocking and clerical help are not

pharmacy technicians.

"Practitioner" means an individual currently licensed, registered or otherwise authorized by

the jurisdiction in which the individual practices to administer or prescribe drugs and/ or devices

in the course of professional practice.

"Prescription" means a lawful order of a practitioner for a drug, device or diagnostic agent for

a specific patient.

"Professional judgment" means judiciousness and discretion based upon thorough

knowledge and sound application of the specialized body of knowledge specific to the practice of

pharmacy, and an understanding of the relationship of this knowledge and its application to the

well-being of the patient and to the judgment of the practitioner.

“Therapeutically equivalent” means a therapeutic equivalence rating of “A” as has been listed

by the Federal Food and Drug Administration in the “Approved Drug Products with Therapeutic

Equivalence Evaluations,” sometimes referred to as the “Orange Book.”

13:39-1.3 FEE SCHEDULE

a) The following fees shall be charged by the Board:

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For pharmacists as follows:

i) Application for licensure ................................................................... $125.00

ii) Verification of licensure ..................................................................... $ 25.00

iii) Application for reciprocity ................................................................. $125.00

iv) Application for reinstatement

(1) Disciplinary suspension ............................................................. $225.00

(2) Administrative suspension ......................................................... $225.00

v) Initial license fee

(1) If paid during the first year of a biennial renewal period ........... $140.00

(2) If paid during the second year of a biennial renewal period ....... $ 70.00

vi) Biennial license renewal .................................................................. $140.00

vii) Replacement biennial license ........................................................... $ 25.00

viii) Inactive license renewal ................(To be determined by future rulemaking)

ix) Late renewal fee ............................................................................... $100.00

x) Replacement fee of initial wall license .............................................. $ 40.00

xi) Continuing education review fee ....................................................... $ 10.00

xii) Continuing education program or course: sponsor review fee ......... $ 50.00

For in-State pharmacies as follows:

i) Pharmacy permits

(1) Application for permit ................................................................. $275.00

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(2) Annual permit renewal ............................................................... $175.00

(3) Change of ownership/name ....................................................... $275.00

(4) Change of location ..................................................................... $275.00

ii) Replacement of annual permit .......................................................... $ 25.00

iii) Late renewal fee ............................................................................... $100.00

iv) Verification of permit ......................................................................... $ 25.00

For pharmacy technicians as follows:

i) Application for registration ................................................................ $ 50.00

ii) Initial registration fee:

(1) If paid during the first year of a biennial renewal period ............ $ 70.00

(2) If paid during the second year of a biennial period .................... $ 35.00

iii) Biennial registration renewal ............................................................. $ 70.00

iv) Replacement biennial registration .................................................... $ 25.00

v) Late renewal fee ............................................................................... $ 25.00

vi) Verification of registration .......................................................... $25.00; and

vii) Reinstatement fee:

(1) Disciplinary suspension ............................................................. $125.00

(2) Administrative suspension ......................................................... $125.00

For out-of-State pharmacies as follows:

i) Pharmacy permits

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(1) Application for permit ................................................................. $275.00

(2) Annual permit renewal ............................................................... $175.00

(3) Change of ownership/name ....................................................... $275.00

(4) Change of location ..................................................................... $275.00

ii) Replacement of annual permit .......................................................... $ 25.00

iii) Late renewal fee ............................................................................... $100.00

iv) Verification of permit ......................................................................... $ 25.00

For pharmacy interns as follows:

i) Application for registration ................................................................ $ 50.00

ii) Initial registration fee ......................................................................... $ 70.00

iii) Registration renewal (One time only) ............................................... $ 70.00

13:39-1.4 PAYMENT OF PENALTIES

a) Any penalties levied by the Board shall be paid within 15 business days of the finalization

of a penalty letter or final order of the Board unless otherwise prescribed by statute or

terms of a final order.

b) Failure to comply with this rule may result in action by the Board according to the

provisions of N.J.S.A. 45:1-24.

13:39-1.5 OPPORTUNITY TO BE HEARD

a) Any time the Board seeks to impose a disciplinary sanction upon a licensee, the licensee

may request an opportunity to be heard by the Board.

b) When demonstrated facts are in dispute, a hearing shall be conducted pursuant to the

Administrative Procedure Act, N.J.S.A. 52:14B-1 et seq., and the Uniform Administrative

Procedure Rules, N.J.A.C. 1:1.

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13:39-1.6 WAIVER

a) The rules in this chapter may be relaxed by the Board upon a showing of undue

hardship, economic or otherwise, on an applicant; that the waiver of the rule would not

unduly burden any affected parties; and that the waiver is consistent with the underlying

purposes of the Pharmacy Practice Act, N.J.S.A. 45:14-40 et seq. and the implementing

rules of this chapter.

b) Waiver requests shall be submitted to the Board in writing and shall include the following:

The specific rule(s) or part(s) of the rule(s) for which the waiver is requested;

The reasons for requesting the waiver, including a statement detailing the hardship

that would result to the applicant if the waiver is not approved; and

Documentation which supports the applicant's request for the waiver, if applicable.

c) Absent a request for a waiver, the Board may waive the rules in this chapter if full

compliance with the rules, or parts of the rules, would endanger the health, safety and

welfare of the general public.

13:39-1.7 FAILURE TO COMPLETE APPLICATION PROCESS

If an applicant for a permit, license, or registration issued pursuant to the requirements of

this chapter fails to complete the application process within one year of the date of initial

application, the Board shall administratively close the application. Following such action, an

applicant making reapplication to the Board shall resubmit all required documentation and the

applicable application fee set forth at N.J.A.C. 13:39-1.3.

13:39-1.8 COMPLIANCE WITH POLICY AND PROCEDURES

A pharmacist-in-charge, pharmacist, pharmacy technician, pharmacy extern, pharmacy

intern, and pharmacy permit holder shall comply with the policies and procedures required in this

chapter, as applicable.

13:39-1.9 CONTINUOUS QUALITY IMPROVEMENT PROGRAM

a) A pharmacy permit holder and registered pharmacist-in-charge shall implement a

continuous quality improvement program (CQI) to detect, identify, and prevent

prescription errors.

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The primary purpose of the CQI shall be to advance error prevention by analyzing,

individually and collectively, investigative and other pertinent data collected in

response to a prescription error to assess the cause and any contributing factors,

such as system or process failures.

b) The continuous quality improvement program shall be set forth in the pharmacy's written

policies and procedures manual and, at a minimum, include:

Required documentation including, but not limited to:

i) Incident reports;

ii) Resolutions;

iii) Root cause analyses;

iv) CQI program meeting minutes and attendance records; and

v) Corrective action plans;

An internal incident reporting system;

Assessment of prescription errors to determine the cause of the error;

The appropriate response to the error; and

Meetings conducted at least once every three months, to discuss the results of, and

any issues identified from, the continuous quality improvement program, and any

corrective action plans. Meetings shall be conducted in-person or through live,

interactive webinars and must include, at a minimum, those personnel involved in an

error under review and their supervisors. The pharmacy permit holder must document

that pharmacy personnel who did not attend the CQI meeting have received the CQI

meeting minutes and that the pharmacy permit holder has communicated any

changes to policies and procedures resulting from a CQI meeting with those

personnel affected by such changes.

c) A pharmacy permit holder shall use the findings of its continuous quality improvement

program to develop pharmacy systems and workflow processes designed to prevent

prescription errors, as well as communicate those findings to all pharmacy personnel.

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d) For a pharmacy that submits quality-related events to a patient safety organization (PSO)

for primary quality improvement, the Board shall deem the pharmacy as having a

continuous quality improvement program if the PSO satisfies the minimum requirements

of this section.

e) Notwithstanding compliance with a continuous quality improvement program or

participation in a patient safety organization, in accordance with N.J.A.C. 13:45C-1, each

licensee, registrant, and permit holder retains a duty to cooperate with each Board

inquiry, inspection, or investigation.

SUBCHAPTER 2.

REQUIREMENTS FOR INITIAL LICENSURE

13:39-2.1 REQUIREMENTS FOR INITIAL LICENSURE AS A PHARMACIST

a) An applicant for initial licensure as a pharmacist in New Jersey shall satisfy the following

requirements:

The applicant shall be at least 18 years of age and shall submit a completed

application for initial licensure, which shall include a passport size photo of the

applicant and the application fee set forth in N.J.A.C. 13:39-1.3;

The applicant shall have graduated with either a degree of Bachelor of Science in

pharmacy with a minimum five-year course of study, or with a Doctor of Pharmacy,

from a school or college of pharmacy accredited by the Accreditation Council for

Pharmacy Education (ACPE) or deemed ACPE-equivalent by ACPE;

i) The applicant shall submit an official transcript from the registrar of the school or

college of pharmacy substantiating that the applicant has graduated;

ii) An applicant who has received a pharmacy degree from a school or college of

pharmacy located in a foreign country that has not been accredited by ACPE or

has not been deemed ACPE-equivalent by ACPE, shall satisfy the requirements

of (b) below;

The applicant shall have passed the North American Pharmacist Licensure

Examination (NAPLEX) and the Multistate Pharmacy Jurisprudence Examination

(MPJE), consistent with the requirements of N.J.A.C. 13:39-2.2. The applicant shall

take the NAPLEX and the MPJE only after providing the Board with an official

transcript and receiving authorization to test from the National Association of Boards

of Pharmacy (NABP). An applicant who has already taken the NAPLEX and has had

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his or her scores transferred to New Jersey within five years of having passed the

examination consistent with N.J.A.C. 13:39-2.2, shall take the MPJE only after

providing the Board with an official transcript and receiving authorization to test from

NABP allowing the applicant to be admitted to the MPJE examination;

If the applicant is applying for initial licensure more than two years following his or

her graduation from pharmacy school, the applicant shall complete 1,440 hours of

practical experience in a Board-approved internship. The applicant shall register with

the Board as an intern and shall satisfy all internship requirements set forth in

N.J.A.C. 13:39-2.6 within the two-year period immediately preceding the date of

application; and

The applicant shall have satisfied the good moral character and criminal history

background check requirements set forth in N.J.A.C. 13:39-2.3 and 2.4.

b) An applicant for initial licensure as a pharmacist in New Jersey who has graduated from a

school or college of pharmacy in a foreign country that has not been accredited by ACPE or

has not been deemed ACPE-equivalent by ACPE, shall satisfy the following requirements:

The applicant shall be at least 18 years of age and shall submit a completed

application for initial licensure, which shall include a passport size photo of the

applicant and the application fee set forth in N.J.A.C. 13:39-1.3;

The applicant shall have graduated with either a degree of Bachelor of Science in

pharmacy with a minimum five-year course of study or with a Doctor of Pharmacy;

The applicant shall have a valid certification from the Foreign Pharmacy Graduate

Examination Committee (FPGEC) of NABP;

The applicant shall complete 1,440 hours of practical experience in a Board-

approved internship. The applicant shall register with the Board as an intern and shall

satisfy all internship requirements set forth in N.J.A.C. 13:39-2.6 within the two-year

period immediately preceding the date of application. The internship shall not

commence before the applicant has been certified by FPGEC;

The applicant shall have passed the NAPLEX and the MPJE, consistent with the

requirements of N.J.A.C. 13:39-2.2. The applicant shall take the NAPLEX and the

MPJE only after providing the Board with an official transcript and receiving

authorization to test from NABP. An applicant who has already taken the NAPLEX

and has had his or her scores transferred to New Jersey within five years of having

passed the examination consistent with N.J.A.C. 13:39-2.2, shall take the MPJE only

after providing the Board with an official transcript and receiving authorization to test

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from NABP allowing the applicant to be admitted to the MPJE examination. An

applicant shall not be eligible to take the referenced examination until the completion

of his or her internship; and

The applicant shall have satisfied the good moral character and criminal history

background check requirements set forth in N.J.A.C. 13:39-2.3 and 2.4.

13:39-2.2 LICENSURE EXAMINATION SCORES

a) An applicant for initial licensure shall attain a passing score of not less than 75 on the

North American Pharmacist Licensure Examination (NAPLEX). If an applicant fails the

NAPLEX, he or she shall be required to repeat the examination.

b) An applicant for initial licensure shall attain a passing score of not less than 75 on the

Multistate Pharmacy Jurisprudence Examination (MPJE). If an applicant fails the MPJE,

he or she shall be required to repeat the examination.

c) NAPLEX and MPJE results shall be valid only for a period of five years from the date that

an applicant receives a passing score on the respective examination.

13:39-2.3 PROOF OF CHARACTER

a) An applicant for initial licensure shall submit evidence of good moral character, which

shall be an ongoing requirement for licensure. In determining whether the applicant shall

be licensed in the State, the Board shall consider evidence, which demonstrates that the

applicant:

Is not presently engaged in drug or alcohol use that is likely to impair the ability to

practice pharmacy with reasonable skill and safety. For purposes of this section, the

term "presently" means at this time or any time within the previous 365 days;

Has not been convicted of violating any law of this State or any other state of the

United States relating to controlled dangerous substances or other habit-forming

drugs;

Has not been convicted of violating any law relating to the practice of pharmacy

consistent with N.J.S.A. 45:1-21(f);

Has not been convicted of a crime involving moral turpitude; and

Has not had his or her license or, if a permit holder, his or her permit, suspended or

revoked as a result of any administrative or disciplinary proceedings in this or any

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other jurisdiction which proved the applicant to be in violation of any laws, rules or

regulations pertaining to the practice of pharmacy, and that the applicant is not

currently under suspension or revocation.

13:39-2.4 CRIMINAL HISTORY BACKGROUND CHECK

An applicant for initial licensure as a pharmacist in the State shall submit his or her name,

address and fingerprints for purposes of a criminal history background check to be conducted by

the State of New Jersey pursuant to N.J.S.A. 45:1-28 et seq., P.L. 2002, c. 104, to determine

whether criminal history record information exists which may be considered by the Board in

determining whether the applicant shall be licensed in the State.

13:39-2.5 REFUSAL TO LICENSE

The Board may refuse to issue a license to any applicant who has violated any law related to

the practice of pharmacy or for any of the reasons set forth in N.J.S.A. 45:1-21 et seq.

13:39-2.6 INTERNSHIP AND EXTERNSHIP PRACTICAL EXPERIENCE

REQUIREMENTS

a) The following words and terms, when used in this section, shall have the following

meanings, unless the context clearly indicates otherwise.

"Extern preceptor" means an individual approved by an Accreditation Council for

Pharmacy Education (ACPE)-approved school or college of pharmacy, at which a pharmacy

extern is enrolled, who assumes the responsibility to supervise and provide instructional

training to a pharmacy extern.

"Intern preceptor" means a pharmacist licensed in this State who assumes the

responsibility to supervise and provide instructional training to a pharmacy intern as set forth

in (f) below.

"Pharmacy extern" means any person who is in the fifth or sixth college year, or the third

or fourth professional year, at an ACPE-approved school or college of pharmacy who is

assigned to a pharmacy training site for the purpose of acquiring practical experience under

the supervision of the school or college at which he or she is enrolled.

"Pharmacy intern" means a person who is employed in an approved pharmacy training

site for the purpose of acquiring practical experience and who has first registered for such

purposes with the Board pursuant to N.J.S.A. 45:14-48b(2), and who:

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Has graduated from an ACPE-approved school or college of pharmacy who is making

an application for initial licensure as a pharmacist;

Has graduated from a school or college of pharmacy in a foreign country that has not

been accredited by ACPE or that has not been deemed ACPE-equivalent by ACPE;

Has applied to the Board for reciprocal licensure and has not been engaged in the

practice of pharmacy for at least 1,500 hours within the two-year period immediately

preceding the date of application; or

Is a graduate student participating in a post-graduate pharmacy residency program

accredited by the American Society of Health-System Pharmacists (ASHP) and who

is awaiting initial licensure.

"Pharmacy internship or externship" means the program in which practical experience is

acquired by a pharmacy intern or extern.

"Pharmacy training site" means a site that is licensed by the Board where drugs are

dispensed or pharmaceutical care is provided by a licensed pharmacist and that has a

satisfactory record of observance of Federal, State and municipal law and ordinances

governing the activities in which it is or has been engaged.

b) The 1,440 hours of practical experience required for the successful completion of a

pharmacy internship shall be obtained consistent with the following:

The 1,440 hours of practical experience shall be completed in no less than 34 weeks

and no more than 104 weeks, under the supervision of an intern preceptor. Each

week of practical experience shall consist of no less than 15 hours and no more than

45 hours of actual service per week;

The intern preceptor and the pharmacy intern shall keep accurate records of the time

spent by the pharmacy intern for credit toward the requirements of (b)1 above. The

Board shall provide appropriate forms to be submitted to the Board for approval of

internship experience; and

No credit shall be given for hours served as a pharmacy intern prior to the applicant's

registration with the Board and approval of the intern preceptor by the Board.

c) A pharmacist who wishes to be an intern preceptor shall apply to the Board and shall

furnish evidence that he or she:

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Has been licensed and employed on a full-time basis as a pharmacist in the area of

practice in which he or she is to be engaged as a preceptor for at least two years

immediately preceding the date of application and is currently engaged in the practice

of pharmacy in the State of New Jersey; and

Has not been convicted of a crime or offense relating adversely to the practice of

pharmacy consistent with N.J.S.A. 45:1-21(f) or a crime of moral turpitude and has

not been the subject of disciplinary action taken by a professional board resulting in

the suspension, revocation or surrender of a license or the placement of significant

limitations on such license.

d) The Board shall approve an intern preceptor selected by each pharmacy intern prior to

the beginning of the internship. An intern preceptor shall not supervise the training of

more than one pharmacy intern at a time.

e) The intern preceptor in a pharmacy training site shall provide the Board with a detailed

written report outlining the progress, aptitude and readiness to practice of any pharmacy

intern under his or her supervision at the conclusion of the internship.

f) The intern preceptor shall be responsible for supervising the activities of the pharmacy

intern and providing the pharmacy intern with experience and knowledge related to the

preceptor's area of practice.

g) An individual who works at a pharmacy outside the scope of his or her school’s

supervision is not deemed to be a pharmacy extern as defined in this section and shall

individual may perform only the duties set forth in N.J.A.C. 13:39-6.15.

13:39-2.7 PHARMACY INTERN REGISTRATION REQUIREMENTS

a) No person shall be employed as a pharmacy intern until he or she has been registered

with the Board pursuant to this section and his or her preceptor has been approved by

the Board pursuant to N.J.A.C. 13:39-2.6(c).

b) An applicant for registration as a pharmacy intern shall submit a written application, on a

form supplied by the Board, and shall submit:

His or her name, address and fingerprints for purposes of a criminal history

background check to be conducted by the State of New Jersey pursuant to N.J.S.A.

45:1-28 et seq., (P.L. 2002, c. 104) to determine whether criminal history record

information exists that may disqualify the applicant from being registered as a

pharmacy intern by the Board;

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A passport size photo of the applicant;

Evidence of good moral character, which shall be an ongoing requirement for

registration. In determining whether the applicant shall be registered, the Board shall

consider evidence, which demonstrates that the applicant:

i) Is not presently engaged in drug or alcohol use that is likely to impair the ability to

practice as a pharmacy intern with reasonable skill and safety. For purposes of

this section, the term "presently" means at the time of application or any time

within the previous 365 days;

ii) Has not been convicted of violating any law of this State or any other state of the

United States relating to controlled dangerous substances or other habit-forming

drugs;

iii) Has not been convicted of violating any law relating to the practice of pharmacy

consistent with N.J.S.A. 45:1-21(f) or a crime of moral turpitude; and

iv) Has not had his or her authority to engage in the activity regulated by the Board

suspended or revoked as a result of any administrative or disciplinary

proceedings in this or any other jurisdiction that determined the applicant to be in

violation of any laws, rules or regulations pertaining to the practice of pharmacy

and that the applicant is not currently under suspension or revocation; and

The application fee and registration fee set forth at N.J.A.C. 13:39-1.3.

c) A person who has been educated in a foreign country in a college or school of pharmacy

that has not been approved by the Accreditation Council for Pharmacy Education (ACPE)

or that has not been deemed ACPE-equivalent by ACPE, shall be certified by the Foreign

Pharmacy Graduate Examination Committee (FPGEC) of the National Association of

Boards of Pharmacy prior to applying to the Board for registration as a pharmacy intern.

d) A pharmacy intern registration obtained pursuant to this section shall be valid for a

period of two years from the date of issuance. Upon application to the Board, an intern

registration may be renewed one time only, on an individual basis, for reasons of military

service, hardship, illness or disability.

e) A change in an intern preceptor shall require prior Board approval, consistent with the

requirements of N.J.A.C. 13:39-2.6(d). The new intern preceptor shall be responsible for

making application to the Board for approval.

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f) The intern preceptor and the pharmacy intern shall notify the Board in writing within 10

days of a change in the pharmacy training site and/or the termination or resignation of

the intern.

g) In addition to the notification requirements of (f) above, a pharmacy intern shall notify the

Board in writing within 10 days of any change in his or her name or address of record, as

defined in N.J.A.C. 13:39-1.2.

13:39-2.8 (RESERVED)

13:39-2.9 (RESERVED)

13:39-2.10 (RESERVED)

13:39-2.11 (RESERVED)

13:39-2.12 (RESERVED)

13:39-2.13 (RESERVED)

13:39-2.14 (RESERVED)

13:39-2.15 (RESERVED)

13:39-2.16 (RESERVED)

13:39-2.17 (RESERVED)

13:39-2.18 (RESERVED)

13:39-2.19 (RESERVED)

13:39-2.20 (RESERVED)

SUBCHAPTER 2A.

REQUIREMENTS FOR RECIPROCAL LICENSURE

13:39-2A.1 REQUIREMENTS FOR RECIPROCAL LICENSURE

a) Reciprocal licensure of out-of-State pharmacists shall be limited to those pharmacists

who have been duly licensed in mutually reciprocating states and who satisfy the

requirements of this section.

b) A pharmacist currently licensed in a mutually reciprocating jurisdiction shall satisfy the

following requirements in order to obtain a license by reciprocity in New Jersey:

The applicant shall be at least 18 years of age and shall submit a completed

application for reciprocity, including a passport size photo of the applicant and the

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application fee set forth in N.J.A.C. 13:39-1.3. The application shall substantiate that

the applicant:

i) Has obtained his or her initial licensure by examination and that the initial license

is in good standing; and

ii) Has not had any other license granted to the applicant by any other state

suspended, revoked or otherwise restricted for any reason except for the failure

to renew, or for the failure to obtain the required continuing education credits in

any state where the applicant is currently licensed but is not engaged in the

practice of pharmacy;

The applicant shall have graduated with either a degree of Bachelor of Science in

pharmacy with a minimum five-year course of study, or a Doctor of Pharmacy degree,

from a college or school of pharmacy that has been accredited by the American

Council of Pharmaceutical Education (ACPE), or that has been deemed ACPE-

equivalent by ACPE.

i) An applicant who has received a pharmacy degree from a school or college of

pharmacy located in a foreign country that has not been accredited by ACPE or

that has not been deemed ACPE-equivalent by ACPE, who wishes to obtain a

license by reciprocity in this State shall satisfy the requirement of (c) below;

The applicant shall have engaged in the practice of pharmacy for a period of at least

1,500 hours within the two-year period immediately preceding the date of application;

or shall have registered with the Board as an intern and shall have satisfied all

internship requirements set forth in N.J.A.C. 13:39-2.6 within the two-year period

immediately preceding the date of application;

The applicant shall have passed the Multistate Pharmacy Jurisprudence Examination

(MPJE), consistent with N.J.A.C. 13:39-2A.5. The applicant shall take the MPJE only

after submitting all required documentation to the Board and receiving authorization

to test from the National Association of Boards of Pharmacy (NABP); and

The applicant shall have satisfied the good moral character and criminal history

background check requirements set forth in N.J.A.C. 13:39-2A.2 and 2A.4.

c) A pharmacist currently licensed in a mutually reciprocating jurisdiction who received a

pharmacy degree from a school or college of pharmacy located in a foreign country that

has not been accredited by ACPE or that has not been deemed ACPE-equivalent by

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ACPE, who wishes to obtain a license by reciprocity in this State shall satisfy the

following requirements:

The applicant shall be at least 18 years of age and shall submit a completed

application for reciprocity, including a passport size photo of the applicant and the

application fee set forth in N.J.A.C. 13:39-1.3. The application shall substantiate that

the applicant:

i) Has obtained his or her initial licensure by examination and that the initial license

is in good standing; and

ii) Has not had any other license granted to the applicant by any other state

suspended, revoked or otherwise restricted for any reason except for the failure

to renew, or for the failure to obtain the required continuing education credits in

any state where the applicant is currently licensed but is not engaged in the

practice of pharmacy;

The applicant shall have a valid certification from the Foreign Pharmacy Graduate

Examination Committee (FPGEC) of NABP;

The applicant shall have graduated with either a degree of Bachelor of Science in

pharmacy with a minimum five-year course of study or a Doctor of Pharmacy degree;

The applicant shall have engaged in the practice of pharmacy for a period of at least

1,500 hours within the two-year period immediately preceding the date of application.

i) An applicant who has engaged in the practice of pharmacy for less than 1,500

hours, shall register with the Board as an intern and shall satisfy all internship

requirements set forth in N.J.A.C. 13:39-2.6 within the two-year period

immediately preceding the date of application;

The applicant shall have passed the Multistate Pharmacy Jurisprudence Examination

(MPJE), consistent with N.J.A.C. 13:39-2A.5. The applicant shall take the MPJE only

after submitting all required documentation to the Board and receiving authorization

to test from NABP; and

The applicant shall have satisfied the good moral character and criminal history

background check requirements set forth in N.J.A.C. 13:39-2A.2 and 2A.4.

d) In addition to the requirements set forth in (a) and (b) above, an applicant for licensure

by reciprocity shall meet all licensure transfer criteria utilized by NABP.

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13:39-2A.2 PROOF OF CHARACTER

a) An applicant for licensure by reciprocity shall submit, as part of his or her licensure

application, evidence of good moral character, which shall be an ongoing requirement for

licensure. In determining whether the applicant shall be licensed in the State, the Board

shall consider evidence, which demonstrates that the applicant:

Is not presently engaged in drug or alcohol use that is likely to impair the ability to

practice pharmacy with reasonable skill and safety. For purposes of this section, the

term "presently" means at this time or any time within the previous 365 days;

Has not been convicted of violating any law of this State or any other state of the

United States relating to controlled dangerous substances or other habit-forming

drugs;

Has not been convicted of violating any law relating to the practice of pharmacy

consistent with N.J.S.A. 45:1-21(f);

Has not been convicted of a crime involving moral turpitude; and

Has not had his or her license suspended or revoked as a result of any disciplinary

proceedings in this or any other jurisdiction, which proved the applicant to be in

violation of any laws, rules or regulations pertaining to the practice of pharmacy and

that the applicant is not currently under such suspension or revocation.

13:39-2A.3 REFUSAL TO LICENSE

The Board may refuse to issue a license to any applicant for licensure by reciprocity that has

violated any law relating to the practice of pharmacy or for any of the reasons set forth in

N.J.S.A. 45:1-21 et seq.

13:39-2A.4 CRIMINAL HISTORY BACKGROUND CHECK

An applicant for licensure by reciprocity in the State shall submit his or her name, address

and fingerprints for purposes of a criminal history background check to be conducted by the

State of New Jersey pursuant to N.J.S.A. 45:1-28 et seq., P.L. 2002, c.104, to determine

whether criminal history record information exists which may be considered by the Board in

determining whether the applicant shall be licensed in the State.

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13:39-2A.5 MULTISTATE PHARMACY JURISPRUDENCE EXAMINATION

An applicant for reciprocal licensure shall pass the Multistate Pharmacy Jurisprudence

Examination. A passing score of not less than 75 shall be attained. If an applicant fails the

examination, he or she shall be required to repeat the examination.

SUBCHAPTER 3.

PHARMACIST REQUIREMENTS

13:39-3.1 AUTHORIZATION TO PRACTICE; DISPLAY OF LICENSE

a) An applicant who has successfully satisfied all Board requirements for licensure and has

been approved by the Board to be licensed shall receive an authorization signed by the

Executive Director of the Board granting the applicant the right to practice pharmacy in

the State of New Jersey until such time as an initial license may be issued. The licensee

shall maintain such authorization on his or her person at all times while engaging in the

practice of pharmacy until the initial license is issued.

b) Upon issuance of a license, the current biennial renewal license shall be conspicuously

displayed in view of the public in the pharmacist's principal place of employment.

c) A pharmacist who is employed by more than one pharmacy in the State shall maintain

the wallet-sized license issued by the Board on his or her person when he or she is

working at a location where his or her current biennial renewal license is not on display.

13:39-3.2 REPLACEMENT LICENSE

A replacement initial license or renewal license shall be issued by the Board upon payment

of a fee as prescribed in N.J.A.C. 13:39-1.3 and upon submission of proof of the applicant's

identity and reasonable proof of the loss or destruction of the initial license or renewal license, or

upon return of the damaged initial license or renewal license to the Board.

13:39-3.3 CHANGE OF NAME

If a pharmacist legally changes the name under which he or she engages in the practice of

pharmacy, the pharmacist shall notify the Board within 30 days of such change. The pharmacist

shall submit original proof of the change of name or a certified copy of the court order or

marriage certificate, which shall be retained by the Board. When a replacement license is

issued, the initial license shall be returned for cancellation and the pharmacist shall remit the

required fee as prescribed in N.J.A.C. 13:39-1.3.

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13:39-3.4 CHANGE OF ADDRESS OF RECORD; SERVICE OF PROCESS

a) A pharmacist shall notify the Board in writing of any change in his or her address of

record within 30 days.

b) Failure to notify the Board of any change in a pharmacist's address of record pursuant to

(a) above may result in disciplinary action in accordance with N.J.S.A. 45:1-21(h) and

N.J.A.C. 13:45C-1.3, and the imposition of penalties set forth in N.J.S.A. 45:1-25.

c) Service of any administrative complaint or other Board-initiated process at a pharmacist's

address of record shall be deemed adequate notice for the purposes of N.J.A.C. 1:1-7.1

and the commencement of any disciplinary proceedings.

13:39-3.5 VERIFICATION OF LICENSURE

A verification that the license of a pharmacist is in good standing shall be supplied by the

Board upon written request and upon payment of the fee set forth in N.J.A.C. 13:39-1.3.

13:39-3.6 REPRODUCTION OF LICENSE PROHIBITED

The biennial license or wallet-sized license issued by the Board to any pharmacist shall not

be reprinted, photographed, photostated, duplicated or reproduced by any other means either in

whole or in part, except as provided in N.J.A.C. 13:39-3.2.

13:39-3.7 LICENSE RENEWAL

a) The Board shall send a notice of renewal to each licensee, at least 60 days prior to the

expiration of the license. The notice of renewal shall explain inactive renewal and advise

the licensee of the option to renew as inactive. If the notice to renew is not sent 60 days

prior to the expiration date, no monetary penalties or fines shall apply to the holder for

failure to renew provided that the license is renewed within 60 days from the date the

notice is sent or within 30 days following the date of license expiration, whichever is

later.

b) A licensee shall renew his or her license for a period of two years from the last expiration

date. The licensee shall submit a renewal application to the Board, along with the

renewal fee set forth in N.J.A.C. 13:39-1.3, prior to the date of license expiration.

c) A licensee may renew his or her license by choosing inactive status. A licensee electing

to renew his or her license as inactive shall not engage in the practice of pharmacy, or

hold himself or herself out as eligible to engage in the practice of pharmacy, in New

Jersey until such time as the license is returned to active status.

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d) If a licensee does not renew the license prior to its expiration date, the licensee may

renew the license within 30 days of its expiration by submitting a renewal application, a

renewal fee, and a late fee as set forth in N.J.A.C. 13:39-1.3. During this 30-day period,

the license shall be valid and the licensee shall not be deemed practicing without a

license.

e) A licensee who fails to submit a renewal application within 30 days of license expiration

shall have his or her license suspended without a hearing.

f) A licensee who continues to engage in the practice of pharmacy with a suspended

license shall be deemed to be engaging in the unauthorized practice of pharmacy and

shall be subject to action consistent with N.J.S.A. 45:1-14 et seq., even if no notice of

suspension has been provided to the individual.

13:39-3.8 LICENSE REACTIVATION

a) A licensee who holds an inactive license pursuant to N.J.A.C. 13:39-3.7(c) may apply to

the Board for reactivation of the inactive license. A licensee seeking reactivation of an

inactive license shall submit:

A renewal application;

A certification of employment listing each job held during the period the license was

inactive, which includes the name, address, and telephone number of each employer;

The renewal fee for the biennial period for which reactivation is sought as set forth in

N.J.A.C. 13:39-1.3.

i) If the renewal application is sent during the first year of the biennial period, the

applicant shall submit the renewal fee as set forth in N.J.A.C. 13:39-1.3.

ii) If the renewal application is sent during the second year of the biennial period, the

applicant shall submit one-half of the renewal fee as set forth in N.J.A.C. 13:39-1.3;

and

Evidence of having completed all continuing education credits that were required to

be completed during the biennial period immediately prior to the renewal period for

which reactivation is sought, consistent with the requirements set forth in N.J.A.C.

13:39-3A.1.

i) An applicant who holds a valid, current license in good standing issued by another

state to engage in the practice of pharmacy and submits proof of having satisfied that

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state’s continuing education requirements for that license, shall be deemed to have

satisfied the requirements of this paragraph. If the other state does not have any

continuing education requirements, the requirements of this paragraph apply.

b) If a Board review of an application establishes a basis for concluding that there may be

practice deficiencies in need of remediation prior to reactivation, the Board may require

the applicant to submit to and successfully pass an examination or an assessment of

skills, a refresher course, or other requirements as determined by the Board prior to

reactivation of the license. If that examination or assessment identifies deficiencies or

educational needs, the Board may require the applicant, as a condition of reactivation of

licensure, to take and successfully complete any education or training or to submit to any

supervision, monitoring, or limitations as the Board determines is necessary to assure

that the applicant practices with reasonable skill and safety. The Board, in its discretion,

may restore the license subject to the applicant’s completion of the training within a

period of time prescribed by the Board following the restoration of the license. In making

its determination whether there are practice deficiencies requiring remediation, the Board

shall consider the following non-exhaustive issues:

Length of time license was inactive;

Employment history;

Professional history;

Disciplinary history and any action taken against the applicant’s license or

registration by any licensing board;

Actions affecting the applicant’s privileges taken by any institution, organization, or

employer related to the practice of pharmacy or other professional or occupational

practice in New Jersey, any other state, the District of Columbia, or in any other

jurisdiction;

Pending proceedings against a professional or occupational license issued to the

licensee by a professional board in New Jersey, any other state, the District of

Columbia, or in any other jurisdiction; and

Civil litigation related to the practice of pharmacy or other professional or

occupational practice in New Jersey, any other state, the District of Columbia, or in

any other jurisdiction.

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13:39-3.9 LICENSE REINSTATEMENT FROM ADMINISTRATIVE AND DISCIPLINARY

LICENSE SUSPENSIONS

a) A licensee who has had his or her license administratively suspended pursuant to

N.J.A.C. 13:39-3.7(e) may apply to the Board for reinstatement. A licensee applying for

reinstatement shall submit:

A reinstatement application;

A certification of employment listing each job held during the period of suspended

license, which includes the names, addresses, and telephone number of each

employer;

The renewal fee for the biennial period for which reinstatement is sought;

The past due renewal fee for the biennial period immediately preceding the renewal

period for which reinstatement is sought;

The reinstatement fee set forth in N.J.A.C. 13:39-1.3; and

Evidence of having completed all continuing education credits that were required to

be completed during the biennial period immediately prior to the renewal period for

which reinstatement is sought, consistent with the requirements set forth in N.J.A.C.

13:39-1.3.

i. An applicant who holds a valid, current license in good standing issued by another

state to engage in the practice of pharmacy and submits proof of having satisfied that

state’s continuing education requirements for that license, shall be deemed to have

satisfied the requirements of this paragraph. If the other state does not have any

continuing education requirements, the requirements of this paragraph apply.

b) If a Board review of an application establishes a basis for concluding that there may be

practice deficiencies in need of remediation prior to reinstatement, the Board may require

the applicant to submit to and successfully pass an examination or an assessment of

skills, a refresher course, or other requirements as determined by the Board prior to

reinstatement of the license. If that examination or assessment identifies deficiencies or

educational needs, the Board may require the applicant as a condition of reinstatement

of licensure to take and successfully complete any education or training or to submit to

any supervision, monitoring, or limitations as the Board determines is necessary to

assure that the applicant practices with reasonable skill and safety. The Board, in its

discretion, may restore the license subject to the applicant’s completion of the training

within a period of time prescribed by the Board following the restoration of the license. In

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making its determination whether there are practice deficiencies requiring remediation,

the Board shall consider the following non-exhaustive issues:

Length of time license was suspended;

Employment history;

Professional history;

Disciplinary history and any action taken against the applicant’s license by any

licensing board;

Actions affecting the applicant’s privileges taken by any institution, organization, or

employer related to the practice of pharmacy or other professional or occupational

practice in New Jersey, any other state, the District of Columbia, or in any other

jurisdiction;

Pending proceedings against a professional or occupational license/registration or

certificate issued to the licensee by a professional board in New Jersey, any other

state, the District of Columbia, or in any other jurisdiction; and

Civil litigation related to the practice of pharmacy or other professional or

occupational practice in New Jersey, any other state, the District of Columbia, or in

any other jurisdiction.

c) A pharmacist who has had his or her license suspended pursuant to disciplinary action

taken by the Board may apply to the Board for reinstatement of his or her license at the

conclusion of the suspension period. A pharmacist applying for reinstatement from a

disciplinary suspension shall submit:

A reinstatement application, including an affidavit of employment listing each job held

during the period of license suspension, including the names, addresses, and

telephone numbers of each employer;

A reinstatement fee set forth in N.J.A.C. 13:39-1.3;

The applicable renewal fee(s) set forth in N.J.A.C. 13:39-1.3; and

4. Evidence of having met all conditions imposed by the Board pursuant to the disciplinary

and/or reinstatement order(s).

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13:39-3.10 STEERING PROHIBITED

It shall be unlawful for a pharmacist to enter into an arrangement with a health care

practitioner who is licensed to issue prescriptions, or any institution, facility, or entity that

provides health care services, for the purpose of directing or diverting patients to or from a

specified pharmacy or restraining in any way a patient's freedom of choice to select a pharmacy.

13:39-3.11 RESPONSIBILITIES OF PHARMACISTS

a) All pharmacists shall be responsible for compliance with all the rules, regulations and

laws governing the practice of pharmacy.

b) Any pharmacist found to have violated the New Jersey Pharmacy Practice Act, N.J.S.A.

45:14-40 et seq., or the rules in this chapter, shall be subject to disciplinary action.

SUBCHAPTER 3A.

CONTINUING EDUCATION

13:39-3A.1 CONTINUING EDUCATION CREDIT HOUR REQUIREMENTS

a) Each applicant for biennial license renewal shall complete a minimum of 30 credits of

continuing education during the preceding biennial period, except that the Board shall not

require completion of continuing education credits for an applicant's initial license

renewal. At least 10 of the continuing education credits shall be obtained through didactic

instruction. For purposes of this subsection, "didactic instruction" means in-person

instruction and may include telephonic or electronic instruction that is interactive, but

shall not include videotaped instruction. At least three continuing education credits shall

be obtained in pharmacy law applicable to the practice of pharmacy in New Jersey.

Commencing with the biennial renewal period beginning on May 1, 2017, at least one of

the 30 continuing education credits shall, pursuant to P.L. 2017, c. 28, be in educational

programs or topics concerning prescription opioid drugs, including alternatives to opioids

for managing and treating pain, and the risks and signs of opioid abuse, addiction, and

diversion. This one credit shall not be eligible for carry-over as described in (b) below.

In accordance with P.L. 2017, c. 28, if the Board deems it appropriate, on an

individual basis, the Board may waive the specific one credit continuing education

requirement concerning prescription opioid drugs. Any such waiver request shall be

filed pursuant to N.J.A.C. 13:39-3A.5.

b) Ten credits of continuing education may be carried over into a succeeding biennial

period only if such credits were earned during the last six months of the preceding

biennial period and were not previously reported.

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c) Each applicant for biennial license renewal who is authorized to administer vaccines and

related emergency medications and who seeks renewal of Board approval granted

pursuant to N.J.A.C. 13:39-4.21 shall complete the continuing education requirements

set forth in that section. The Board shall consider these hours of continuing education

towards the total number of credits required in (a) above.

d) Each applicant for biennial license renewal who is granted authorization to engage in

collaborative drug therapy management shall complete the continuing education

requirements set forth in N.J.A.C. 13:39-13.3. The Board shall consider these hours of

continuing education towards the total number of credits required in (a) above.

13:39-3A.2 CRITERIA FOR CONTINUING EDUCATION CREDIT

a) A licensee may obtain continuing education credit from the following categories:

Programs or courses offered by Accreditation Council for Pharmacy Education

(ACPE)-approved providers;

Programs and courses that have received prior Board approval pursuant to N.J.A.C.

13:39-3A.6;

Graduate course work relevant to the practice of pharmacy, taken at an accredited

college or university, beyond that required for professional licensure;

Participation in teaching and/or research appointments;

Participation as a preceptor in externship programs;

Participation as a preceptor in internship programs; and

Publication of an article related to the practice of pharmacy in a peer-reviewed

professional journal.

13:39-3A.3 CONTINUING EDUCATION CREDIT HOUR CALCULATIONS

a) Credit for continuing education shall be granted as follows for each biennial license

period:

Attendance at approved programs or courses shall be granted one credit for each

hour of attendance. Credit shall not be granted for programs or courses which are

less than one contact hour in duration, which is defined as 50 minutes of actual

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attendance in a program or course of study. One half credit shall be granted for each

30 minute segment of a program or course that is more than one contact hour in

duration. Completion of an entire program or course is required in order to receive

any continuing education credit for the program or course.

Successful completion of graduate course work related to the practice of pharmacy at

an accredited college or university beyond that which is required for professional

licensure shall be granted three continuing education credits for each course credit

awarded.

Teaching and research appointments related to the practice of pharmacy shall be

granted three continuing education credits for each new program or course taught or

subject matter researched by a licensee, to a maximum of six credits. "New," in this

paragraph, means a program, course or subject matter which the licensee has never

taught or researched before in any educational or practice setting. A licensee who is

employed as a teacher and/or as a researcher on a full-time basis shall not be

eligible to obtain continuing education credit for such activities.

Participation as a preceptor in an externship program, upon prior approval by a

college of pharmacy, shall be granted three continuing education credits per student

to a maximum of six credits.

Participation as a preceptor in an internship program shall be granted three

continuing education credits per 160 hours of work performed by the intern(s) and

supervised by the licensee, to a maximum of six credits.

Publication of an article related to the practice of pharmacy in a peer-reviewed

professional journal shall be granted three continuing education credits per article to

a maximum of six credits.

b) The Board shall not grant credit for, or approve as a component of a continuing

education program, participation in the routine business portion of any meeting of a

pharmaceutical organization or any presentation that is offered to sell a product or

promote a business enterprise.

13:39-3A.4 CONTINUING EDUCATION CREDIT HOUR REPORTING PROCEDURE

a) A licensee shall specify on his or her application for biennial license renewal that the

required number of continuing education credits has been completed. Falsification of any

information contained in the renewal application may result in an appearance before the

Board and the assessment of penalties and/or license suspension pursuant to N.J.S.A.

45:1-21 et seq.

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b) A licensee shall maintain all documentation concerning the completion of continuing

education requirements for a period of five years from the completion of the credit hours

and shall submit such documentation to the Board upon request. Such documentation

shall consist of:

For programs offered by Accreditation Council for Pharmacy Education (ACPE)-

approved providers, a certificate of completion from the course or program or a

transcript from the National Association of Boards of Pharmacy CPE Monitor;

For programs and courses approved by the Board, the sponsors' written verification

of attendance;

For teaching or research appointments in an academic setting, a statement from the

chairperson of the department verifying completion of the assignment;

For research appointments in an industrial setting, a statement from the project

coordinator verifying completion of the assignment;

For participation as a preceptor in an externship program, a certificate from the

college of pharmacy;

For participation as a preceptor in an internship program, a certificate from the Board;

and

For publications in a peer-reviewed professional journal, submission of the published

article.

c) The Board shall audit licensees on a random basis at the end of each biennial period to

determine compliance with continuing education requirements.

13:39-3A.5 WAIVER OF CONTINUING EDUCATION REQUIREMENTS

a) The Board may waive continuing education requirements on an individual basis for

reasons of military service, hardship, illness or disability.

b) A licensee seeking a waiver of continuing education requirements shall apply to the

Board in writing and set forth with specificity the reasons for requesting the waiver. The

licensee shall also provide the Board with such additional information as the Board may

request in support of the application for waiver.

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c) A waiver of continuing education requirements granted pursuant to this section shall be

effective only for the biennial period in which such waiver is granted. If the condition(s)

which necessitated the waiver continues into the next biennial period, a licensee shall

apply to the Board for a renewal of such waiver for the new biennial period.

13:39-3A.6 RESPONSIBILITIES OF CONTINUING EDUCATION SPONSORS

a) A continuing education sponsor shall receive prior Board approval for a program or

course if the sponsor provides, in writing on a form provided by the Board, information

which demonstrates that the program or course meets the following requirements:

The program or course is offered in a subject matter relevant to the practice of

pharmacy;

The program or course is at least one contact hour in length; and

The program or course is conducted by a qualified instructor or discussion leader

who submits a curriculum vitae and who is:

i) A pharmacist with a B.S. in Pharmacy or a Pharm.D. with at least five years of

experience;

ii) A pharmacist with a B.S. in Pharmacy or a Pharm.D. with expertise in the

program or course subject area;

iii) A pharmacist with a B.S. in Pharmacy or a Pharm.D. who is certified by a

nationally recognized board or association; or

iv) A licensed health care professional who demonstrates special expertise in the

lecture subject area.

b) A continuing education sponsor may request approval for a program or course conducted

by an individual who possesses expertise in a subject area relevant to the practice of

pharmacy, provided that the program or course to be conducted by that individual

satisfies the requirements of (a)1 and 2 above.

c) Applications for pre-approval of continuing education programs or courses shall be

submitted by the continuing education sponsor on a form provided by the Board at least

45 days prior to the date the program or course is to be offered. Incomplete applications

shall be returned to the sponsor.

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d) The Board shall approve only such continuing education programs and courses as are

available and advertised on a reasonable nondiscriminatory basis to all persons licensed

to practice pharmacy in the State. The Board shall maintain a list of all approved

programs and courses at the Board office and shall furnish the list to licensees upon

request.

e) A continuing education sponsor shall not make substantive changes to an approved

program or course, such as a change in program or course content or instructor, without

prior Board approval.

f) The continuing education sponsor shall monitor attendance at, or ensure completion of,

each approved program or course and furnish to each enrollee a verification of

attendance which shall include at least the following information:

The title, date, start and end time, and location of the program or course offering;

The name of the program or course presenter;

The name and certificate number of the program or course presented;

The number of continuing education credits awarded; and

The name, address, telephone number and signature of the sponsor, or if the

sponsor is an association or organization, the signature of an officer or responsible

party of the association or organization.

g) The continuing education sponsor shall submit the fee set forth at N.J.A.C. 13:39-1.3(a)

for each submission of program or course offerings.

h) The continuing education sponsor shall maintain a list of all attendees who completed

each approved program or course for a period of five years from the date the program or

course was offered.

13:39-3A.7 MONITORING OF CONTINUING EDUCATION PROGRAMS OR COURSES

A Board member or a Board representative may monitor an approved program or course

without prior notification to the continuing education sponsor.

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SUBCHAPTER 4.

PHARMACY PERMIT REQUIREMENTS

13:39-4.1 NEW PHARMACIES; PHARMACY DEPARTMENTS; ELIGIBILITY AND

APPLICATION

a) A permit application shall be submitted to the Board by every individual or business entity

desiring to operate a new pharmacy. Such application shall be made on a form furnished

by the Board. If the area for which a pharmacy permit is sought is less than the total area

of the premises, the area subject to permit shall be known as the "pharmacy

department."

b) The permit application shall indicate the exact intended location and plan or physical

arrangement of the proposed pharmacy or pharmacy department area, including any

drive-thru area, and shall indicate any area contiguous or adjacent to but not necessarily

a part of the proposed permitted area, and any area where drugs will be stored and/or

dispensed.

c) The permit application shall include the exact trade name(s), if any; the corporate names,

if any; the name and addresses of the owners and operators, if a sole proprietorship,

partnership, limited liability partnership or limited liability company; the names and

addresses of all officers and stockholders and the names and addresses of all principals

duly licensed to write prescriptions if the pharmacy is not a publicly traded corporation;

and the names and addresses of the officers, if a publicly traded corporation.

d) The permit application shall include the name of the pharmacist-in-charge who shall be a

pharmacist in good standing in the State of New Jersey.

e) No person, business entity or equity holder of the business entity shall be eligible for a

new permit or a renewal thereof who is not of high moral character or against whom

there is pending any indictment or any alleged violation of local, State or Federal law

pertaining to the practice of pharmacy or the dispensing of controlled dangerous

substances or any drug under N.J.S.A. 24:21-2.

f) A person submitting an application may be interviewed by the Board to review his or her

qualifications and eligibility.

g) Before a permit may be issued to an applicant, the Board shall inspect and approve the

premises, fixtures and equipment of the new pharmacy or pharmacy department to

ensure compliance with this subchapter and all relevant statutes, regulations and

ordinances.

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h) Upon approval of the permit application, the Board shall issue a permit number that will

allow the applicant to place prescription legend drugs in stock. A pharmacy shall not sell,

dispense, or distribute any prescription drugs or devices until the pharmacy is open for

business.

i) Within 90 days of the Board’s approval of the permit application, the pharmacy shall

notify the Board in writing that the pharmacy has opened for business. If additional time

beyond the 90 days is needed to open the pharmacy, no less than 30 days prior to the

expiration of the 90-day period, the pharmacy shall submit a written request to the Board

for an extension of time. Such request shall include the reasons an extension is

necessary and the amount of additional time sought. If after the expiration of the 90

days, the pharmacy has not notified the Board that it has opened for business or

requested an extension, the Board shall rescind the pharmacy permit. Following such

action, an applicant making reapplication to the Board shall resubmit all required

documentation and the applicable application fee set forth at N.J.A.C. 13:39-1.3.

13:39-4.2 ISSUANCE OF PERMITS; PERMIT RENEWALS

a) All permits shall be issued by the Board in the name of the pharmacy for the operation of

which the permit is issued.

b) A permit holder shall submit to the Board, on an annual basis, within 30 days after the

permit expiration, a renewal application and the renewal fee set forth in N.J.A.C. 13:39-

1.3. A permit holder that fails to submit the renewal application within 30 days after the

permit expiration shall submit the late renewal fee set forth in N.J.A.C. 13:39-1.3 in

addition to the renewal fee. A permit holder that continues to engage in the practice of

pharmacy with an expired permit shall be deemed to be engaging in the unauthorized

practice of pharmacy and shall be subject to the penalties set forth in N.J.S.A. 45:1-25 et

seq.

c) The Board shall send a notice of renewal to each permit holder, at least 60 days prior to

the expiration of the permit. If the notice to renew is not sent 60 days prior to the

expiration date, no monetary penalty or fines shall apply to the permit holder for any

unauthorized practice during the period following the permit expiration, not to exceed the

number of days short of 60 before the renewal was issued.

13:39-4.3 DISPLAY OF PERMITS

The current permit issued by the Board for the operation of a pharmacy shall be

conspicuously displayed in view of the public.

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13:39-4.4 DEATH OF OWNER OR PARTNER

In the case of death of an individual owner or a partner, the permit issued to the deceased

owner or to the partnership is terminated and shall be returned to the Board pursuant to N.J.A.C.

13:39-4.10. If the operation of the pharmacy is to be continued, the estate or heirs of the

deceased partner and/or the remaining partners shall comply with the requirements set forth at

N.J.A.C. 13:39-4.5.

13:39-4.5 CHANGE OF OWNERSHIP; ASSET ACQUISITION

a) When there is a change in the ownership of a pharmacy or in the ownership of the

business entity holding the pharmacy permit, the following requirements shall be

satisfied, as applicable:

If there is a complete change in ownership, the new owner(s) shall, within 30 days

after the change, submit to the Board a permit application for change of ownership

pursuant to N.J.A.C. 13:39-4.1, the permit application fee set forth in N.J.A.C. 13:39-

1.3, and documentation evidencing the change of ownership. The new owner(s) shall

perform an inventory of the pharmacy's controlled substances consistent with the

requirements of N.J.A.C. 13:45H-5.4 and 5.5, which shall be made available to the

Board upon request. A new permit number shall be issued if a request is made at the

time of the filing of the permit application;

If there is a change of registered agents or officers, the business entity shall, within

30 days after the change, submit to the Board an affidavit indicating the changes that

have taken place and any other information requested by the Board;

If there is a change of stock ownership involving 10 percent or more of the

outstanding stock of a publicly traded corporation, the corporation shall, within 30

days after the change, submit to the Board an affidavit indicating the changes that

have taken place and any other information requested by the Board; and

If a reallocation of ownership interests occurs among existing owners, the owners

shall, within 30 days after the change, submit to the Board an affidavit explaining the

asset reallocation.

b) Upon a change in ownership pursuant to (a) above, the new ownership of such entity

shall take custodial ownership of the previous five years of prescription and profile

records of the previous pharmacy and shall ensure that the prescription and profile

records are maintained pursuant to N.J.A.C. 13:39-7.6 and 7.19 after the date of

acquisition.

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c) Upon the sale, transfer or acquisition of the business assets of a pharmacy, the person

or entity acquiring such assets shall take custodial ownership of the pharmacy's previous

five years of prescription and profile records and shall ensure that the prescription and

profile records are maintained pursuant to N.J.A.C. 13:39-7.6 and 7.19 after the date of

acquisition.

13:39-4.6 (RESERVED)

13:39-4.7 CHANGE OF LOCATION AND/OR ADDRESS OF LICENSED PREMISES

a) When a pharmacy permit holder intends to change the physical location and address of

the permitted premises, the permit holder shall apply to the Board, at least 30 days prior

to such change, for a new pharmacy permit. If the change in location and address will

result in the temporary closing of the pharmacy, the permit holder shall comply with all

requirements set forth at N.J.A.C. 13:39-4.12(c) and (d). The permit holder shall submit a

new permit application pursuant to N.J.A.C. 13:39-4.1 and the new permit application fee

set forth in N.J.A.C. 13:39-1.3. The Board shall issue an amended pharmacy permit

reflecting the new location and address of the pharmacy. Before an amended permit may

be issued to the permit holder for the new location, the Board shall inspect and approve

the premises, fixtures, equipment, and inventory of the new location to ensure

compliance with this subchapter and all relevant statutes, regulations, and ordinances.

The permit holder shall ensure that the prescription and profile records from the

pharmacy's previous location and address are maintained pursuant to N.J.A.C. 13:39-7.6

and 7.19 after the location and address change.

b) Whenever there is a change in a pharmacy's address but no change in the physical

location of the licensed premises, the permit holder shall, within 10 business days of the

change in address, submit an affidavit to the Board explaining such change.

13:39-4.8 REMODELING OF LICENSED PREMISES

a) Prior to the remodeling of a pharmacy or pharmacy department, where such remodeling

entails a change within the premises of the location or size of the prescription area, or a

change in the dimensions of the licensed premises, the permit holder shall notify the

Board at least 30 days in advance on a form prescribed by the Board. The pharmacy

permit holder shall submit plans for the continuation of operations during the remodeling

process which the Board shall review and approve, and the anticipated date of

completion. The permit holder shall ensure compliance with all requirements set forth in

this chapter while services continue during the remodeling process, and if the remodeling

will result in the temporary closing of the pharmacy, the permit holder shall comply with

all requirements set forth at N.J.A.C. 13:39-4.12(c) and (d).

b) The pharmacy permit holder shall notify the Board upon completion of the remodeling

process. Within 60 days of the completion of the remodeling, the Board shall inspect and

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approve the premises, fixtures, equipment and inventory of the remodeled pharmacy to

ensure compliance with this subchapter and all relevant statutes, regulations and

ordinances.

13:39-4.9 CHANGE OF NAME

a) When a pharmacy permit holder intends to change the name of the pharmacy, the permit

holder shall apply to the Board, at least 30 days prior to such change, for an amended

permit. The permit holder shall submit a new permit application pursuant to N.J.A.C.

13:39-4.1 and the new permit application fee set forth in N.J.A.C. 13:39-1.3. The Board

shall issue an amended pharmacy permit reflecting the new name of the pharmacy.

b) The Board shall issue an amended permit bearing the new name upon return of the

permit bearing the previous name to the Board for cancellation and payment of the

permit fee as prescribed in N.J.A.C. 13:39-1.3.

c) If a change in pharmacy name is associated with a change in ownership, the permit

holder shall ensure that the requirements set forth in N.J.A.C. 13:39-4.5 are satisfied.

13:39-4.10 DISCONTINUED PHARMACIES

a) Whenever a pharmacy is to be discontinued and closed for any reason, including

suspension or retirement of the permit holder, sale or insolvency, the permit holder shall

immediately send written notification of the anticipated closing to the State Board of

Pharmacy, the Office of Drug Control and the Drug Enforcement Administration at least

15 days prior to the anticipated closing date. Whenever a pharmacy is to be discontinued

and closed as a result of an unanticipated occurrence, such as the death of the permit

holder, the permit holder's representative shall send written notification to the Board, the

Office of Drug Control and the Drug Enforcement Administration, as soon as possible

prior to the actual closing date. All medications, including prescription legend and

controlled drugs, should be transferred to the holder of a current pharmacy permit; a

wholesaler; a reverse distributor; and/or a manufacturer. All medications not properly

transferred shall remain on the pharmacy premises with all licenses and registrations in

effect until such medications are disposed of in the manner prescribed by the Board, the

Office of Drug Control and/or the Drug Enforcement Administration.

b) Within 30 days of closing a pharmacy pursuant to (a) above, the permit holder or his or

her representative shall remove all drug signs from both the inside and outside of the

discontinued pharmacy and shall notify the Board in writing of the location of the previous

five years of prescription and patient profile records, consistent with the requirements of

N.J.A.C. 13:39-7.6 and 7.19. The permit holder or his or her representative shall return

the permit to the Board for cancellation within 30 days of the closing. Prescription

records and other information may be requested by the Board as outlined in N.J.A.C.

13:39-7.6 and 7.19.

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13:39-4.11 AVAILABILITY OF RECORDS UPON TERMINATION OF BUSINESS OR

CHANGE OF OWNERSHIP

a) When a pharmacy ceases operation as the result of a suspension, retirement, or death of

the owner, sale, or other cause including insolvency, the permit holder, or the one

responsible for supervising the disposition of the practice, shall make every effort to

notify patrons that they have the right to obtain copies of currently valid prescriptions

and/or copies of their patient profile and the location of the prescriptions and patient

profile for a one-year period following notice, using all of the following methods:

Notification in writing to the Board;

Publication, once weekly for two successive weeks in a newspaper whose circulation

encompasses the geographic area in which the pharmacy is located, of a notice

advising patrons that they have the right to obtain copies of their prescriptions and/or

patient profile, and the location of the prescriptions and patient profile for a one-year

period following publication;

A sign placed in the pharmacy location informing the patrons that they have the right

to obtain copies of their prescriptions and/or patient profile, and the location of the

prescriptions and patient profile; and

For a permitted pharmacy that uses social media that is specific to individually

identified locations, the pharmacy shall post notice on all social media platforms used

by the pharmacy informing patrons of the pharmacy closure, that they have a right to

obtain copies of their prescriptions and/or patient profile, and the location of the

prescriptions and patient profile. The pharmacy shall also discontinue and remove all

commercial advertising from social media sites.

b) Upon a sale of assets or a change in ownership pursuant to N.J.A.C. 13:39-4.5(a), both

the new and former pharmacy permit holders shall ensure that there is access to patient

prescription and profile records within 24 hours of the transfer of business assets, and

that all telephone calls to the former pharmacy shall be forwarded to the new pharmacy.

13:39-4.12 BUSINESS HOURS; UNAUTHORIZED CLOSING

a) All pharmacies shall be kept open for the transaction of business at least 40 hours per

week and at least five days per week.

b) If any permanent changes are made in the opening or closing hours of a pharmacy, the

Board office shall be notified in writing of these changes within 30 days.

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c) A notice shall be conspicuously displayed on the exterior of any pharmacy indicating any

temporary changes in the opening or closing hours of the pharmacy, or indicating a

temporary closing of the pharmacy whenever such changes occur.

d) Any temporary closing of a pharmacy for more than 48 hours shall be reported to and

approved by the Board. Notification to the Board shall include contingency plans for

accessing patient records. Any temporary closing of more than 48 hours without prior

Board approval shall result in the pharmacy being deemed a discontinued pharmacy

requiring compliance with the requirements of N.J.A.C. 13:39-4.10 and 4.11.

13:39-4.13 REPLACEMENT PERMIT

A replacement permit may be issued by the Board upon payment of a fee pursuant to

N.J.A.C. 13:39-1.3 and submission of an affidavit describing the loss or destruction of the permit

originally issued, or upon return of the damaged permit.

13:39-4.14 REPRODUCTION OF PERMITS

a) Any permit issued by the Board for the operation of a pharmacy may be copied only for

State agencies and other business entities with whom the permit holder does pharmacy

related business.

b) Any reproduction of a pharmacy permit by a permit holder for any unlawful purpose shall

subject a permit holder to disciplinary action pursuant to N.J.S.A. 45:1-21.

13:39-4.15 SECURITY OF PHARMACIES AND PHARMACY DEPARTMENTS

a) The pharmacist(s) on duty in all pharmacies, including pharmacy departments, shall be

responsible for:

Keeping the pharmacy or pharmacy department closed and the security system

turned on at all times when he or she is not present within the permitted premises in

the case of a pharmacy, or, in the case of a pharmacy department, when he or she is

not present within the department, except as provided in N.J.A.C. 13:39-6.4;

i) In the case of a pharmacy or pharmacy department that has been issued an

institutional permit, pharmacy technicians may remain within the permitted

premises when the pharmacy or pharmacy department is closed and secured, if

the pharmacist determines, based on his or her professional judgment, that the

security of prescription legend drugs, devices and controlled substances will be

maintained in the pharmacist's absence;

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Ensuring that the security of the prescription dispensing area and its contents are

maintained at all times, including the restriction of persons unauthorized by the

pharmacist on duty from being present in the prescription dispensing area; and

Reporting all thefts or diversions of prescription legend drugs and devices and

controlled substances, and any significant loss of prescription legend drugs and

devices and controlled substances, to the pharmacist-in-charge or the pharmacy

permit holder upon discovery. When determining whether a loss of prescription

legend drugs or devices or controlled substances is significant, the following factors

shall be considered, consistent with 21 CFR 1301.74(c):

i) The actual quantity of prescription legend drugs, devices or controlled substances

missing in relation to the type of business;

ii) The specific prescription legend drug, device or controlled substance missing;

iii) Whether the loss of the prescription legend drug, device or controlled substance

can be associated with access to those drugs, devices or controlled substances

by specific individuals, or whether the loss can be attributed to unique activities

that may take place involving the drugs, devices or controlled substances;

iv) A pattern of losses over a specific time period, whether the losses appear to be

random and the results of efforts taken to resolve the losses;

v) If known, whether the specific prescription legend drugs, devices or controlled

substances are likely candidates for theft or diversion; and

vi) Local trends and other indicators of the theft or diversion potential of the missing

prescription legend drug, device or controlled substance.

b) The holder of a pharmacy or pharmacy department permit and the pharmacist-in-charge

of the pharmacy or pharmacy department shall ensure that:

All entrances to the pharmacy or pharmacy department are capable of being locked

and are connected to a monitored security system that transmits an audible, visual or

electronic signal warning of intrusion. The security system shall be equipped with a

back-up mechanism to ensure notification or continued operation if the security

system is tampered with or is disabled. Only the pharmacist-in-charge shall be

responsible for the security of the keys and the security system access code to the

pharmacy or pharmacy department;

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If a theft or diversion of prescription legend drugs or devices or controlled

substances, or a significant loss of prescription legend drugs or devices or controlled

substances, as delineated in (a) above, is reported to the pharmacist-in-charge, the

pharmacist-in-charge shall notify the holder of the pharmacy or pharmacy department

permit of such report. The pharmacist-in-charge and the holder of the pharmacy or

pharmacy department permit shall ensure that:

i) A written report is filed with the Board upon discovery of the theft or diversion or

the significant loss of prescription legend drugs or devices; and

ii) A written report is filed with the Federal Drug Enforcement Administration upon

discovery of the theft or diversion or any significant loss of controlled substances,

consistent with Federal requirements. A copy of such report shall be filed with the

Office of Drug Control, consistent with State requirements and with the Board;

There is a secure area for receiving packages known to contain prescription legend

drugs and devices and controlled substances. No prescription drug shall be accepted

during the hours the pharmacy or pharmacy department is closed unless adequate

security for the storage of such shipments has been provided; and

If a drop-off device is utilized for prescriptions, it is of a one-way, irretrievable and

secure design.

c) In addition to the requirements set forth in (b) above, the holder of a pharmacy

department permit and the pharmacist-in-charge of the pharmacy department shall also

ensure that:

The pharmacy department is constructed so as to enable the closing off and securing

of the department from the main store area. The department shall be separated from

the main store area by a secured barrier or partition extending from the floor or fixed

counter to the ceiling of either the department or main store and attached thereto;

All medications requiring supervision of a pharmacist, including dispensed

medication, remain within the confines of the department when the pharmacist is not

in the pharmacy department;

If the pharmacy department has a published telephone number that is the same as

the one for the establishment in which the department is located, the caller is able to

select the service or department to which he or she wants to be connected; and

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The telephone number of the pharmacist-in-charge is available in the office of the

manager of the establishment.

d) The holder of a pharmacy or pharmacy department permit shall comply with any law

and/or ordinance of the municipality in which the pharmacy or pharmacy department is

located requiring the placement of a security key box on the exterior of the pharmacy or

the premises in which the pharmacy department is located for purposes of permitting

emergency access to the premises.

13:39-4.16 PERMITS; SPECIALIZED PERMITS

a) The Board may issue a special permit, wherein the type of service is of a limited nature.

The permit so issued, being based on special conditions of use imposed by the Board,

may necessitate the waiver of certain rule requirements.

b) Specialized permits shall pertain to pharmacies providing specific services as may be

necessary and proper to efficiently meet a limited public need for pharmaceutical

services. An applicant for any specialized pharmacy permit shall provide the Board with

an application and a policy and procedure manual which sets forth a detailed description

of the type of specialized pharmacy services to be provided within the pharmacy

practice. The policy and procedure manual shall also contain detailed provisions which

ensure the protection of the public welfare as determined by the Board.

13:39-4.17 STEERING PROHIBITED

It shall be unlawful for a pharmacy permit holder to enter into an arrangement with a

practitioner, or any institution, facility, or entity that provides health care services, for the

purpose of directing or diverting patients to or from a specified pharmacy for the filling of

prescriptions or restraining in any way a patient's freedom of choice to select a pharmacy.

13:39-4.18 RESPONSIBILITIES OF PERMIT HOLDERS

a) All permit holders shall be responsible for compliance with all the rules, regulations and

laws governing the practice of pharmacy.

b) Any permit holder may be held liable for violations of the New Jersey Pharmacy Practice

Act, N.J.S.A. 45:14-40 et seq., and the rules in this chapter and may be subject to

disciplinary action.

13:39-4.19 PROCEDURES FOR CENTRALIZED PRESCRIPTION HANDLING

a) The four component functions of handling a prescription are intake, processing,

fulfillment and dispensing.

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b) Central prescription handling entails two or more licensed pharmacies sharing

responsibility for performing the four component functions of handling a prescription. For

purposes of this section, the term "prescription" shall include medication orders when a

healthcare facility is involved in any of the component functions of central prescription

handling.

c) The following pharmacies may engage in central prescription handling: an intake or

originating pharmacy; a central processing pharmacy; a central fill pharmacy; and a

dispensing pharmacy. The four component functions of handling a prescription shall be

performed by the following pharmacies:

An intake or originating pharmacy, which is a pharmacy that received the patient's or

prescribing practitioner's request to fill or refill a prescription. A central processing

pharmacy or a central fill pharmacy, as delineated in (c)2 and 3 below, may be

considered the intake or originating pharmacy if the prescription was transmitted by

the prescribing practitioner directly to the centralized pharmacy as provided in

N.J.A.C. 13:39-7.10 and 7.11 or if the patient requested the refill from that pharmacy;

A central processing pharmacy, which is a pharmacy that engages in prescription

review by performing functions that may include, but are not limited to, data entry,

prospective drug review, refill authorizations, interventions, patient counseling, claims

submission, claims resolution and adjudication;

A central fill pharmacy, which is a pharmacy engaging in central prescription handling

by filling and/or refilling prescriptions, which includes the preparation and packaging

of the medication; and

A dispensing pharmacy, which is a pharmacy that receives the processed

prescription and/or the filled or refilled prescription for dispensing to the patient or to

the patient's authorized representative and that offers patient counseling regarding

the dispensed medication.

d) Two or more of the pharmacies delineated in (c) above may engage in central

prescription handling provided:

Any or all of the pharmacies participating in central prescription handling have a

contractual agreement to provide such services or have the same owner;

Prior to engaging in central prescription handling, all pharmacies that are parties to

the central prescription handling obtain Board approval. If a participating pharmacy is

located outside the State of New Jersey, the pharmacy shall have registered with the

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Board pursuant to N.J.A.C. 13:39-4.20. The pharmacies shall make a single

application to the Board, delineating the scope of practice of each pharmacy and the

specific rules in this chapter with which each pharmacy shall comply;

An audit trail is maintained that records and documents the unique and secure user

identifier(s) of the pharmacist(s), pharmacy technician(s), intern(s) or extern(s) and

the component function(s) performed by each, at the time the functions are

performed, for each step of prescription handling that is required to be performed by

a pharmacist, pharmacy technician, intern or extern pursuant to the requirements of

this chapter. All steps performed by a pharmacy technician, intern or extern shall be

documented in the audit trail. All entries to the audit trail made by a pharmacy

technician, intern or extern shall be reviewed and approved by the pharmacist. When

more than one pharmacist is involved in the component functions of prescription

handling, the unique and secure user identifier(s) of the pharmacist(s) responsible for

the accuracy and appropriateness of each component function(s) shall be recorded in

the audit trail. The audit trail and prescription information shall be maintained or

stored in original hard copy form or in any other media that facilitates the

reproduction of the original hard copy and shall be maintained for not less than five

years from the date the prescription is filled or refilled. The oldest four years of

information shall be maintained in such a manner so as to be retrievable and

readable within two weeks. The most recent one year of information shall be

retrievable and readable within one business day. Records not currently in use need

not be stored in the pharmacy, but the off-site facilities used to store such records

shall be secure. Patient records shall be kept confidential, but shall be made

available to persons authorized to inspect them under State and Federal statutes and

regulations;

The dispensed prescription for any product bears a permanently affixed label with at

least the following information:

i) The brand name, or if a generic, the brand name, if still available in the

marketplace, and the name of the generic in the following form, with the generic

name and brand name inserted as appropriate:

“----------- Generic for -------------"

If the brand name is not still available in the marketplace, the generic

name.

ii) The strength of medication, where applicable;

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iii) The quantity dispensed;

iv) The date upon which prescription medication is dispensed;

v) A CDS cautionary label, where applicable and when permitted by law;

vi) The patient name;

vii) The practitioner name;

viii) The prescription number;

ix) Directions for use;

x) The phrase "use by" followed by the product's use by date, if dispensed in any

packaging other than the manufacturer's original packaging. For purposes of this

paragraph, "use by date" means the earlier of one year from the date of

dispensing or the expiration date on the manufacturer's container;

xi) All auxiliary labeling as recommended by the manufacturer and/or as deemed

appropriate in the professional judgment of the dispensing pharmacist;

xii) The name, address, and telephone number of any or all of the following:

(1) The intake pharmacy;

(2) The central processing pharmacy;

(3) The central fill pharmacy; and/or

(4) The dispensing pharmacy; and

xiii) For substituted biological products, the information required in N.J.A.C. 13:39-

7.23(d).

The patient name, the brand or generic name of the medication, and the directions

for use appear in larger type, in a different color type, or in bolded type, in

comparison to the other information required to appear on the label of the dispensed

container pursuant to (d)4 above;

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The patient is provided with written information, either on the prescription label or

with the prescription container, that indicates which pharmacy to contact if the patient

has any questions about the prescription or the medication. The written information

provided to the patient shall be in bold print, easily read, and shall include the hours

a pharmacist is available and a telephone number where a pharmacist may be

reached. The telephone service shall be available at no cost to the pharmacy's

primary patient population;

All pharmacies that are to engage in central prescription handling maintain a common

policies and procedures manual which designates who shall be responsible for each

of the component functions of handling the prescription and for ensuring compliance

with the Board rules set forth in this chapter. The policies and procedures manual

shall also include maintenance of the audit trail required by (d)3 above. The policies

and procedures manual shall be made available to the Board upon request;

All pharmacies that are to engage in central prescription handling share a common

electronic file; and

All pharmacies that are to engage in central prescription handling are responsible for

ensuring that the prescription has been properly filled.

e) A prescription for a controlled substance may be filled or refilled by pharmacies engaging

in central prescription handling when permitted by law, consistent with Federal

requirements set forth at 21 CFR 1300 et seq.

13:39-4.20 OUT-OF-STATE PHARMACY REGISTRATION

a) Any pharmacy located in a state other than New Jersey (hereinafter "out-of-State

pharmacy") that ships, mails, distributes or delivers in any manner, legend drugs or

devices or controlled dangerous substances pursuant to a prescription into the State, or

which participates in a central prescription handling arrangement pursuant to N.J.A.C.

13:39-4.19, shall be registered with the Board pursuant to this section.

b) It shall be unlawful for any out-of-State pharmacy not registered with the Board pursuant

to this section to ship, mail, distribute or deliver in any manner, legend drugs or devices

or controlled dangerous substances pursuant to a prescription into the State of New

Jersey. Such conduct shall be deemed a violation of N.J.S.A. 45:14-73 and this section.

c) An out-of-State pharmacy seeking to register with the Board shall submit a completed

application for registration to the Board, which shall include the following:

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The name under which the pharmacy is to be operated, the type of practice in which

the pharmacy will be engaging, the weekly hours of operation for the pharmacy, and

a copy of the prescription label to be used by the pharmacy;

The location, names and titles of all principal corporate officers, if the applicant is a

corporation, or the location, names and titles of any individuals in whom ownership is

or will be vested, if the applicant is not a corporation;

The name of the pharmacist-in-charge and his or her license number in the state in

which the pharmacy is located, and his or her weekly hours of employment;

A dated copy of the most recent inspection report resulting from an inspection within

the past two years of the out-of-State pharmacy conducted by the regulatory or

licensing agency in the state in which the pharmacy is located;

A letter of good standing from the state licensing authority in the state in which the

licensed, permitted or registered out-of-State pharmacy is located; and

The application fee specified in N.J.A.C. 13:39-1.3.

d) An out-of-State pharmacy registered with the Board shall maintain, at all times, a valid

unexpired license, permit, or registration to conduct the pharmacy in compliance with the

laws and regulations of the state in which it is located. The pharmacy shall notify the

Board immediately upon the permanent closing of the pharmacy or upon the

commencement of any action by the licensing authority in the state in which it is located

concerning its license, permit or registration to conduct the pharmacy. Suspension or

revocation of a pharmacy's license, permit or registration in the state in which it is

located shall result in the immediate commencement of proceedings by the Board to

suspend or revoke the out-of-State pharmacy's registration in New Jersey.

e) An out-of-State pharmacy registered with the Board shall submit on an annual basis,

prior to the expiration of the registration, a renewal application which shall contain the

information set forth in (c)1 through 5 above, and the renewal fee set forth in N.J.A.C.

13:39-1.3. A registered out-of-State pharmacy that fails to submit the renewal application

within 30 days after the registration expiration shall submit the late renewal fee set forth

in N.J.A.C. 13:39-1.3 in addition to the renewal fee. An out-of-State pharmacy that

continues to ship, mail, distribute or deliver legend drugs or devices or controlled

dangerous substances into the State, or continues to participate in a central prescription

handling arrangement pursuant to N.J.A.C. 13:39-4.19, with an expired registration shall

be deemed to be engaging in the unauthorized practice of pharmacy and shall be subject

to the penalties set forth in N.J.S.A. 45:1-25 et seq.

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f) An out-of-State pharmacy registered with the Board shall submit an application for

registration pursuant to (c) above and the fee set forth in N.J.A.C. 13:39-1.3, within 30

days after the following:

A complete change in ownership. The new owner(s) shall also submit documentation

evidencing the change of ownership. A new registration number shall be issued if a

request is made at the time of the filing of the application;

A change in the location of the licensed, permitted, or registered pharmacy; or

A change in the name of the licensed, permitted, or registered pharmacy.

g) An out-of-State pharmacy registered with the Board shall submit to the Board an affidavit

indicating the changes that have taken place and any other information requested by the

Board within 30 days after the following, as applicable:

A change of registered agents or officers;

A change of stock ownership involving 10 percent or more of the outstanding stock of

a publicly traded corporation;

A reallocation of ownership interests among existing owners; or

A change in the pharmacist-in-charge. When there is a change in the pharmacist-in-

charge, the affidavit shall contain the information set forth in (c)3 above.

h) An out-of-State pharmacy may obtain a replacement registration upon payment of the fee

specified in N.J.A.C. 13:39-1-3 and upon submission of an affidavit describing the loss or

destruction of the registration originally issued, or upon return of the damaged permit.

i) An out-of-State pharmacy registered with the Board shall:

Inform the Board, upon request, of the results of any inspections or investigations

conducted by the regulatory or licensing agency of the state in which the pharmacy is

licensed, permitted or registered or by a Federal agency, including the filing of any

action against the pharmacy by the agency;

Inform the Board, upon request, of any directions to, and requests for information

from, the pharmacy issued by the regulatory or licensing agency of the state in which

the pharmacy is licensed, permitted or registered or by a Federal agency; and

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Comply with directions concerning compliance with this section and any requests for

information issued by the Board.

j) An out-of-State pharmacy registered with the Board shall maintain its record of

prescriptions for patients in the State of New Jersey for a period of not less than five

years. The oldest four years of record information shall be maintained in such a manner

so as to be retrievable and readable within two weeks. The most recent one year of

record information shall be retrievable and readable within one business day.

k) An out-of-State pharmacy registered with the Board shall, during its regular hours of

operation, but not less than five days per week, and for a minimum of 40 hours per week,

provide a toll-free telephone service to facilitate communication between patients in the

State of New Jersey and a pharmacist who has access to the patients' records. This toll-

free number shall be disclosed on a label affixed to each container of drugs dispensed to

patients in the State of New Jersey or the out-of-State pharmacy shall meet the

requirements set forth in N.J.A.C. 13:39-4.19(d)6.

l) The Board may forward a complaint against any out-of-State pharmacy registered with

the Board for alleged violations of any New Jersey or Federal law or regulation, or any

information concerning alleged violations of New Jersey or Federal law by the pharmacy,

to the regulatory or licensing agency in the state in which the pharmacy is located, or the

Board may institute disciplinary proceedings in New Jersey pursuant to N.J.S.A. 45:1-21

et seq., to resolve the complaint or alleged violation.

13:39-4.21 PROCEDURES FOR AUTHORIZED PRESCRIBER ORDERED OR

GOVERNMENT SPONSORED IMMUNIZATIONS PERFORMED BY PHARMACISTS,

PHARMACY INTERNS, OR PHARMACY EXTERNS

a) The following words and terms, when used in this section, shall have the following

meanings, unless the context clearly indicates otherwise.

"Direct supervision" shall have the same meaning as "immediate supervision" as set forth

at N.J.S.A. 45:14-41.

"Supervising pharmacist" means a licensed pharmacist authorized to administer vaccines

and related emergency medications pursuant to the requirements of this section, and

who is responsible for the direct supervision of a registered pharmacy intern or pharmacy

extern administering immunizations to patients pursuant to this section.

b) The provisions of this section set forth the requirements for licensed pharmacists,

registered pharmacy interns, and pharmacy externs authorized to administer vaccines

and related emergency medications, which shall be limited to diphenhydramine and

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epinephrine, to eligible patients who are 18 years of age and older, consistent with the

requirements at N.J.S.A. 45:14-63, under the following circumstances:

Pursuant to a prescription by a New Jersey authorized prescriber for a vaccine,

related emergency medications, and pharmacist, pharmacy intern, or pharmacy

extern administration of the vaccine that is patient specific;

In immunization programs implemented pursuant to a New Jersey authorized

prescriber's standing order for the vaccine, related emergency medications, and

administration instructions that are not patient specific; and/or

In immunization programs sponsored by government agencies that are not patient

specific.

c) In order to administer vaccines and related emergency medications pursuant to this

section, a licensed pharmacist and registered pharmacy intern shall be pre-approved by

the Board to perform such functions. In order to obtain such prior Board approval, a

pharmacist or pharmacy intern shall submit documentation to the Board that establishes

that he or she has satisfied the following education and training requirements:

Completion of an academic and practical curriculum that includes instruction in

Centers for Disease Control and Prevention (CDC) guidelines for vaccine

administrations, set forth in Chapter 6, Vaccine Administration, of "Epidemiology and

Prevention of Vaccine-Preventable Diseases (The Pink Book: Course Textbook),"

updated 13th edition, 2015. The CDC vaccine administration guidelines are

incorporated herein by reference, as amended and supplemented, and can be found

at the CDC website, www.cdc.gov

, specifically,

http://www.cdc.gov/vaccines/pubs/pinkbook/vac-admin.html. The instruction shall be

offered by a provider accredited by the Accreditation Council for Pharmacy Education

(ACPE). The curriculum shall include the following subjects:

i) The Occupational Exposure to Bloodborne Pathogens standard of the

Occupational Health and Safety Administration (OSHA), set forth at 29 C.F.R.

§1910.1030, and the New Jersey Public Employees Occupational Safety and

Health (PEOSH) Act, set forth at N.J.S.A. 34:6A-25 et seq., incorporated herein

by reference;

ii) CDC Guideline for Infection Control in Health Care Personnel (1998). The CDC

Guideline for Infection Control in Health Care Personnel (1998) are incorporated

herein by reference, as amended and supplemented, and can be found at the

CDC website, www.cdc.gov

, specifically,

http://www.cdc.gov/hicpac/pdf/infectcontrol98.pdf;

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iii) Basic immunology;

iv) Communicable or vaccine preventable disease epidemiology;

v) Vaccine characteristics, contraindications, monitoring, proper storage and proper

handling;

vi) Informed consent;

vii) Pre-and post-vaccine assessment and counseling;

viii) Immunization record management;

ix) Immunization schedules established pursuant to "General Recommendations on

Immunization" of the CDC Advisory Committee on Immunization Practices (ACIP)

(December 1, 2006), incorporated herein by reference, as amended and

supplemented. The ACIP recommendations can be found at the CDC website,

www.cdc.gov

, specifically,

http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5515a1.htm;

x) Injection techniques;

xi) Emergency responses to adverse events;

xii) Medical waste disposal; and

xiii) Reporting adverse events;

Current certification in the American Heart Association Basic Life Support (BLS)

protocol, the Red Cross Adult Cardiac Pulmonary Resuscitation (CPR) protocol for

health care providers or in a course that complies with guidelines created by the

International Liaison Committee on Resuscitation (ILCOR). The ILCOR guidelines,

2010 International Consensus on Cardiopulmonary Resuscitation (CPR) and

Emergency Cardiovascular Care (ECC) Science with Treatment Recommendations,

are incorporated herein by reference, as amended and supplemented, and can be

found at the American Heart Association website,

http://americanheart.org/presenter.jhtml?identifier=3022512, specifically,

http://circ.ahajournals.org/content/122/16_suppl_2/S250; and

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For a licensed pharmacist, at least two hours of continuing education in

immunizations, consistent with the requirements at N.J.A.C. 13:39-3A.1, in each

biennial renewal period.

d) In order to administer vaccines and related emergency medications pursuant to this

section, a pharmacy extern shall satisfy the education and training requirements at (c)1

and 2 above, which shall be confirmed by the supervising pharmacist.

e) A registered pharmacy intern or pharmacy extern who administers vaccines and related

emergency medications pursuant to this section shall act under the direct supervision of

the supervising pharmacist

f) Documentation which establishes that a licensed pharmacist, registered pharmacy intern,

or pharmacy extern has satisfied the education and training requirements at (c) above

shall be maintained at the pharmacy practice site. If the immunization program is to take

place somewhere other than the pharmacy practice site, the documentation shall be

maintained in the licensed pharmacist's, registered pharmacy intern's, or pharmacy

extern's, as applicable, possession at the immunization location. Such documentation

shall be made available for inspection by the Board.

g) Board approval granted to a licensed pharmacist and registered pharmacy intern

pursuant to this section shall be renewed on a biennial basis. A pharmacist seeking such

renewal shall submit documentation which establishes that he or she has satisfied the

requirements at (c)2 and 3 above. A registered pharmacy intern seeking such renewal

shall submit documentation that establishes that he or she has satisfied the requirements

at (c)2 above and the number of such renewals shall be consistent with N.J.A.C. 13:39-

2.7(d).

h) An authorized prescriber's standing order shall specify the procedures that shall be

followed for the reporting of adverse events. The licensed pharmacist and supervising

pharmacist shall maintain and adhere to a manual of policies and procedures for dealing

with acute adverse events. The supervising pharmacist shall ensure that a pharmacy

intern and pharmacy extern adheres to the manual of policies and procedures for dealing

with acute adverse events. The policies and procedures manual shall require, at a

minimum, that the pharmacist, pharmacy intern, or pharmacy extern, as applicable,

immediately notify emergency medical personnel and obtain assistance for the patient

when an adverse event requiring the administration of emergency medications occurs.

The policies and procedures manual shall be reviewed annually by the licensed

pharmacist and supervising pharmacist and such review shall be documented.

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i) Authorized prescribers' standing orders shall be maintained in either hard copy or

electronic form as provided at (p) below, and shall be available for inspection by the

Board at the pharmacy practice site and, if applicable, at the immunization location.

j) Before administration of a vaccine, the licensed pharmacist, registered pharmacy intern,

or pharmacy extern, as applicable, shall:

Screen the patient using CDC established criteria for each specific vaccine to be

administered;

Counsel the patient and/or the patient's representative about contraindications,

proper care of the injection site, and instructions to contact a physician or emergency

care facility in the event of any adverse reaction;

Inform the patient and/or the patient's representative in writing, in specific and readily

understood terms, about the risks and benefits of the vaccine and provide the patient

with a vaccine information sheet published by the CDC; and

Obtain a signed informed consent form, which complies with the requirements at (k)

below, from the patient or the patient's representative, which shall be maintained at

the pharmacy practice site. If the immunization program is to take place somewhere

other than the pharmacy practice site, the signed informed consent forms shall be

maintained in the licensed pharmacist's, registered pharmacy intern's, or pharmacy

extern's, as applicable, possession at the immunization location, and then transferred

to the pharmacy practice site. The signed informed consent forms shall be

maintained in either hard copy or electronic form as provided at (p) below.

k) The informed consent form provided by a licensed pharmacist, registered pharmacy

intern, or pharmacy extern, as applicable, to a patient shall contain a check-off box which

authorizes the pharmacist, pharmacy intern, or pharmacy extern, as applicable, to send

copies of the patient's vaccine documentation to the patient's primary care provider, and

another check-off box which prohibits the pharmacist, pharmacy intern, or pharmacy

extern, as applicable, from sending copies of the patient's vaccine documentation to the

patient's primary care provider. The informed consent form shall specify that a patient's

failure to select one of the two check-off boxes shall result in the patient's vaccine

documentation being sent to the patient's primary care provider, if identified.

l) The licensed pharmacist, registered pharmacy intern, or pharmacy extern, as applicable,

shall document all immunizations he or she performs and such documentation shall be

maintained at the pharmacy practice site. If the immunization program is to take place

somewhere other than the pharmacy practice site, the documentation shall be

maintained in the licensed pharmacist's, registered pharmacy intern's, or pharmacy

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extern's, as applicable, possession at the immunization location, and then transferred to

the pharmacy practice site. Such documentation shall be retained in either hard copy or

electronic form, consistent with [(l)] (p) below, and shall be made available for inspection

by the Board. Such documentation shall include:

The patient's name, address, telephone number, date of birth, allergies and gender;

The vaccine administered, the manufacturer, expiration date, lot number, site of

administration, and dose administered;

The date of original order and the date of administration(s);

The name and address of the authorized prescriber and supervising pharmacist, if

applicable, and the name and address of the licensed pharmacist, registered

pharmacy intern, or pharmacy extern administering the dose, and the immunization

location, if different from the pharmacy practice site; and

The name and address of the patient's primary care provider, if provided.

m) The licensed pharmacist or, as applicable, supervising pharmacist for a registered

pharmacy intern or pharmacy extern shall document in detail and immediately report all

clinically significant adverse events to the authorized prescriber, and to the primary care

provider, if identified and if authorized on the informed consent form consistent with (k)

above. The licensed pharmacist or supervising pharmacist, as applicable, shall, within 72

hours, report such events to the appropriate government reporting system.

n) The licensed pharmacist, registered pharmacy intern, or pharmacy extern, as applicable,

shall provide a copy of all patient related documentation and a copy of the signed

informed consent form to each patient receiving an immunization, or to the patient's

representative, to the patient's primary care provider, if provided and if authorized on the

informed consent form consistent with (k) above.

o) The supervising pharmacist or pharmacist-in-charge shall report an immunization

administered to a patient by a pharmacist, pharmacy intern, or pharmacy extern to the

New Jersey Immunization Information System, established pursuant to N.J.S.A. 26:4-

134, as required pursuant to N.J.A.C. 8:57-3.16, for inclusion in the patient's registry.

p) All documentation and records required to be maintained by this section shall be

maintained in either hard copy or electronic form for a period of not less than seven

years from the date of most recent entry and shall be supplied to any physician or health

care provider upon receipt of a signed patient release of health information form. All

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records shall be made available to persons authorized to inspect them under State and

Federal statutes and regulations. The oldest six years of information shall be maintained

in such a manner so as to be retrievable and readable within two weeks. The most recent

one year of information shall be retrievable and readable within one business day.

Records not currently in use need not be stored in the pharmacy, but the storage

facilities shall be secure. Patient records shall be kept confidential.

q) In the case of immunization programs implemented pursuant to a physician's standing

order, a licensed pharmacist shall be supervised by the delegating physician.

Supervision by the delegating physician shall be deemed adequate if the delegating

physician:

Is responsible for formulating or approving a standing order, periodically reviewing

the order and the services provided to patients under the order;

Is geographically located to be easily accessible to the pharmacy practice site and, if

applicable, to the immunization location.

Is available through direct telecommunication for consultation, assistance, and

direction; and

Receives annual status reports on the immunization program as administered by the

pharmacist.

13:39-4.21A REQUIREMENTS FOR PHARMACISTS, PHARMACY INTERNS, AND

PHARMACY EXTERNS TO ADMINISTER INFLUENZA VACCINE TO PATIENTS

UNDER 18 YEARS OF AGE

(a) A licensed pharmacist, registered pharmacy intern, and pharmacy extern must be authorized

to administer vaccines and related emergency medications pursuant to and to comply with the

requirements at N.J.A.C. 13:39-4.21.

(b) For a patient who is under 18 years of age, a licensed pharmacist, registered pharmacy

intern, or pharmacy extern, as applicable, shall obtain the written consent of the patient's parent

or legal guardian.

pharmacist, registered pharmacy intern, or pharmacy extern may administer the influenza

vaccine only pursuant to a prescription by an authorized prescriber.

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(d) A licensed pharmacist, registered pharmacy intern, or pharmacy extern shall not administer

an influenza vaccine to a patient who is younger than seven years of age.

SUBCHAPTER 4A.

REMOTE PROCESSING OF PRESCRIPTIONS

13:39-4A.1 DEFINITIONS

(a) For purposes of this subchapter, the following words shall have the following meanings,

unless the context clearly indicates otherwise:

“Remote location” means a location where the pharmaceutical functions specified in this

subchapter are performed, other than on the premises of a pharmacy. The remote location must

be located in New Jersey or in another state, territory, or possession of the United States whose

regulatory body overseeing the practice of pharmacy is a member of the National Association of

Boards of Pharmacy (NABP).

“Remote processing of prescriptions” means the performance of pharmaceutical functions

specified in this subchapter at a remote location as defined in this section. “Remote processing

of prescriptions” does not:

1. Include the storing or dispensing of any medication; or

2. Involve more than one licensed pharmacy.

13:39-4A.2 REMOTE PROCESSING OF PRESCRIPTIONS BY A NEW JERSEY

PHARMACY

(a) A pharmacy may engage in the remote processing of prescriptions, provided that the

pharmacy complies with the requirements of this subchapter.

(b) A pharmacy that engages in the remote processing of prescriptions shall notify the Board

that it is engaging in the remote processing of prescriptions and shall provide the name of the

pharmacist-in-charge who shall be responsible for ensuring and attesting to compliance with the

requirements of this subchapter. Such notification shall be made on a form supplied by the

Board.

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in the remote processing of prescriptions, on an annual basis, shall have the permit holder and

pharmacist-in-charge attest to compliance with the provisions of this subchapter.

(d) A pharmacy using remote processing of prescriptions shall ensure that:

A pharmacist performing pharmaceutical functions at the remote location holds an

active New Jersey pharmacist license in good standing;

A pharmacy technician performing pharmaceutical functions at the remote location

holds an active New Jersey pharmacy technician registration in good standing; and

All pharmaceutical functions performed by a pharmacy technician at a remote

location are reviewed and approved by a licensed pharmacist.

(e) A pharmacist or pharmacy technician performing pharmaceutical functions for a pharmacy at

a remote location shall be an employee of the pharmacy.

(f) A pharmacy engaging in remote processing of prescriptions shall have the following:

A written policy and procedures manual maintained pursuant to this section;

A certification by the pharmacist-in-charge that all pharmacy technicians performing

pharmaceutical functions at a remote location are registered with the Board pursuant

to N.J.A.C. 13:39-6.6;

The address of the remote location(s) and a description of the work environment

consistent with the requirements at (l ) below;

The security controls to ensure the confidentiality of all patient information consistent

with the requirements at (m) below;

The names and license or registration numbers of all personnel performing

pharmaceutical functions at the remote location(s); and

A certification from each person performing pharmaceutical functions at the remote

location(s) that the training described at (i)2 and 3 below has been completed.

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(g) A pharmacy may allow a pharmacist at a remote location to perform only the following

pharmaceutical functions using technology consistent with (k) below:

Receipt, interpretation, and clarification of prescription orders received from a

prescriber;

i) Prescription shall only be in electronic format subject to the security requirements

set forth at (k) below. Prescriptions or other health care information shall not be

utilized, maintained, or stored in hard copy format at the remote location;

Data entry of prescription medication information;

) Prospective drug utilization review;

Refill authorizations;

Product verification provided that there is compliance with the restrictions set forth at

(p) below;

) Interventions;

) Patient counseling;

) Claims submission; and

) Claims resolution and adjudication.

(h) A pharmacy may allow a registered pharmacy technician to perform only the following

pharmaceutical functions at a remote location using technology consistent with (k) below:

Data entry of prescription medication information;

Refill authorizations consistent with the requirements at N.J.A.C. 13:39-6.15(a)7;

Claims submission; and

Claims resolution and adjudication.

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(i) The pharmacist-in-charge shall be responsible for all pharmaceutical functions performed in

connection with the remote processing of prescriptions. The pharmacist-in-charge shall be

responsible, at a minimum, for ensuring that:

No medications are stored at, or dispensed from, a remote location;

Prior to performing any services in connection with remote processing, all

pharmacists and pharmacy technicians engaged in the remote processing of

prescriptions have received adequate training relevant to performing pharmaceutical

functions at a remote location;

Prior to performing any services in connection with remote processing, all

pharmacists and pharmacy technicians are trained in the pharmacy’s policy and

procedures manual with regard to remote processing of prescriptions;

All pharmaceutical functions performed by a pharmacy technician at a remote

location are reviewed and approved by a New Jersey licensed pharmacist;

The pharmacist or pharmacy technician performing pharmaceutical functions at a

remote location has access to the pharmacy’s electronic prescription files and that

adequate security controls as described at (k) below are in place to ensure the

confidentiality of all patient information; and

There is a policy and procedures manual with regard to the remote processing of

prescriptions that meets the requirements at (j) below.

j) A pharmacy engaging in the remote processing of prescriptions shall operate according to

the pharmacy’s written policy and procedures manual.

The policy and procedures manual shall include, at a minimum, policies and

procedures governing the following:

i) Security controls, including measures to ensure that patient information cannot be

captured, copied, downloaded, printed, reproduced, retained, or stored at a

remote location;

ii) Work environment for the remote location;

iii) Responsibilities of the pharmacist-in-charge;

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iv) Reporting to the Board within seven days of the violations of (m) below and any

incidents of other compliance issues with this subchapter that negatively impact

patient safety;

v) Methods to ensure that a New Jersey licensed pharmacist reviews and approves

all pharmaceutical functions performed by a pharmacy technician at a remote

location;

vi) Methods to ensure that access to the records of medications and other medical

information of the patients maintained by the pharmacy is limited to New Jersey

licensed pharmacists or registered pharmacy technicians approved to have

access to the records, for the purpose of complying with N.J.A.C. 13:39-7.19;

vii) Criteria for selecting employees to engage in the remote processing of

prescriptions; and

viii) Training all of pharmacists and pharmacy technicians engaging in the remote

processing of prescriptions.

The policy and procedures manual shall set forth methods that shall ensure retention

of each amendment, addition, deletion, or other change to the policies and

procedures of operation for at least two years after the change is made. Each change

shall be signed or initialed by the pharmacist-in-charge and shall include the date on

which the pharmacist-in-charge approved the change.

The policy and procedures manual shall be reviewed, at least annually, and updated

if necessary.

A copy of the written policy and procedures manual adopted pursuant to this section

shall be available and immediately accessible at the pharmacy and each remote

location. Upon request, the pharmacy shall provide to the Board a copy of the written

policy and procedures manual for inspection and review.

k) Security controls to ensure the confidentiality of all patient information shall include at

least a two-factor positive authentication of the authorized user, encryption of all data

exchanged between the equipment located at the remote location and pharmacy, and

measures designed to prevent unauthorized storage or transfer of patient information. The

security controls must include measures designed to ensure that patient information cannot

be captured, copied, downloaded, printed, reproduced, retained or stores at a remote

location.

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(l) Remote processing of prescriptions shall be conducted in a work environment that is

conducive to providing quality patient treatment decisions, private counseling, or other

pharmaceutical functions permissible pursuant to this section. Individuals who engage in the

remote processing of prescriptions out of a home environment shall perform the work in a

designated space, and when performing this work, access to the space shall be limited and

not actively used as their primary living, household, or family space. This space shall be

open and accessible for Board inspection. When not in use, process-related documentation

or materials and work equipment shall be properly secured.

(m) All pharmacists and pharmacy technicians participating in the remote processing of

prescriptions shall ensure the confidentiality of patient information in compliance with all

Federal and State laws, rules, and regulations, including the Federal Health Insurance

Portability and Accountability Act of 1996, P.L. 104-191.

(n) A pharmacy engaging in the remote processing of prescriptions shall maintain an audit

trail that records and documents all pharmaceutical functions performed by a pharmacist or

pharmacy technician at a remote location, consistent with the requirements at N.J.A.C.

13:39-7.6.

(o) The remote location shall be considered part of the pharmacy. The remote location and

any equipment and/or devices used in connection with the remote processing of

prescriptions shall be subject to Board inspection.

p) No medications shall be stored at, or dispensed from, a remote location.

13:39-4A.3 REMOTE PROCESSING OF PRESCRIPTIONS BY OUT-OF-STATE

PHARMACY

An out-of-State pharmacy registered with the Board pursuant to N.J.A.C. 13:39-4.20 may

engage in the remote processing of prescriptions that are to be shipped, mailed, distributed, or

delivered to New Jersey, provided that the remote processing of prescriptions is authorized

under the pharmacy laws and regulations in the jurisdiction where the out-of-State pharmacy is

located, and provided that such functions are performed by a pharmacist or pharmacy technician

who is licensed or registered and has been adequately trained, as required by the applicable law

of the out-of-State jurisdiction(s).

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SUBCHAPTER 5.

RETAIL FACILITY REQUIREMENTS

13:39-5.1 PURPOSE AND SCOPE

The rules in this subchapter shall apply to all retail pharmacies, retail pharmacy departments

and all institutional pharmacies filling prescriptions for outpatient use. For purposes of this

subchapter, "pharmacy" means a retail pharmacy, retail pharmacy department or an institutional

pharmacy filling prescriptions for outpatient use.

13:39-5.2 PHARMACY ACCESS AND EGRESS

Pharmacies shall maintain entrances which are easily and safely accessible to the general

public. Access to and egress from the pharmacy shall not be such that the public must traverse

or traffic through any area in which prescriptions are prepared.

13:39-5.3 PHARMACY SIGNS

a) Pharmacies shall post a sign on the exterior of the building or a sign which is otherwise

visible from a public roadway, conspicuously identifying the existence of a pharmacy on

the premises, unless prohibited by lease agreement or municipal ordinance. In such

case, a copy of the lease or ordinance shall be furnished to the Board.

b) Pharmacies shall post the hours that the pharmacy is open and the name of the

pharmacist-in-charge in plain view of the public at all consumer entrances and consumer

access points to the pharmacy, including drive-thru windows and drop-off boxes.

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c) In the case of a pharmacy department, the hours that the department is open and the

name of the pharmacist-in-charge shall be posted in plain view of the public at the

entrance to the department and at all consumer entrances and consumer access points

to the premises, including drive-thru windows and drop-off boxes. When the premises in

which the pharmacy department is located maintains different hours of operation from the

pharmacy department, all advertising, announcements, signs and statements indicating

hours of operation and the presence of the pharmacy department shall clearly and

distinctly indicate the hours that the pharmacy department is open.

13:39-5.4 SPATIAL REQUIREMENT OF PHARMACY PRESCRIPTION AREA

a) For pharmacies in operation prior to July 1, 1963, the space devoted to the prescription

area and laboratory shall not be less than 10 percent of the main floor area of the

pharmacy, and in no instance shall it be less than 50 square feet. If the main floor area of

such pharmacy exceeds 1,200 square feet, the 10 percent requirement does not apply

and the minimum requirement for the prescription area shall not be less than 120 square

feet.

b) For all other pharmacies including pharmacies subject to the provisions of (a) above

which are moving to a new location, the prescription area must occupy exclusively a

minimum of 150 square feet.

13:39-5.5 PRESCRIPTION COUNTER

Pharmacies shall contain a prescription counter or counters on which to work, including

sufficient space for workstation equipment, and the free working space shall not be less than 18

inches in width and not less than 12 total feet in length. This minimum working surface shall be

kept clear at all times for the processing and/or compounding of prescriptions.

13:39-5.6 PRESCRIPTION AREA SINK

An adequate sink with hot and cold running water shall be provided in the prescription area,

easily accessible to the prescription counter.

13:39-5.7 ADEQUATE STORAGE

a) There shall be sufficient shelf, drawer, or cabinet space within the prescription area for

proper storage of prescription drugs and chemicals and the minimum equipment required

pursuant to N.J.A.C. 13:39-5.8.

b) All prescription drugs and chemicals shall be maintained under adequate storage

conditions, including proper lighting, ventilation, and temperature control, as recommended

by the drug manufacturer.

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If storage conditions are not specified by the drug manufacturer, the prescription drug

or chemical shall be maintained according to the parameters set forth in the Drug

Substance Monographs and Excipients of the United States Pharmacopeia/National

Formulary, 2016 edition, incorporated herein by reference, as amended and

supplemented, and which is available for purchase at the United States

Pharmacopeia/National Formulary website at www.usp.org

. Where no specific

directions or limitations are provided in the packaging and storage section of

individual monographs or in the manufacturer specifications, the conditions of storage

shall include storage at a temperature maintained thermostatically between 20 and

25 degrees Celsius (68 and 77 degrees Fahrenheit), protection from moisture, and,

where necessary, protection from light.

13:39-5.8 MINIMUM EQUIPMENT AND SUPPLIES; CLEANLINESS

a) All prescription areas shall contain the following minimum equipment and supplies, which

shall be readily accessible:

1) The most recent edition of comprehensive pharmaceutical reference text(s) and

suitable current reference texts encompassing the pharmaceutical services provided

by the pharmacy, drug interactions, drug product composition and patient counseling.

Unabridged electronic versions of such reference texts shall be acceptable;

Over the counter Schedule V Record Book or an electronic recording system, as

permitted by Federal law pursuant to 21 CFR 1306.26 and 1304.04, to maintain all

required information consistent with N.J.A.C. 13:45H-7.19(a)5, if Schedule V

controlled substances are sold without a prescription;

Permanent prescription filing device and patient profile record system;

Storage place of substantial construction, which is capable of being securely locked

when the pharmacist is not present in the prescription dispensing area, for Schedule

II controlled substances, if not dispersed;

Suitable volumetric devices;

A steel spatula and a spatula of rubber or composition;

Refrigerator, as required by United States Pharmacopoeia Standards, to be used

only for the storage of pharmaceuticals;

Refrigerator thermometer and, if applicable, freezer thermometer, or temperature

monitoring device to enable control of temperature;

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Suitable counting trays or approved counting device;

10)

Labels;

11)

Auxiliary labels;

12)

The signage required pursuant to N.J.S.A. 24:6E-10, the 29th edition of the list of

"Approved Drug Products with Therapeutic Equivalence Evaluations," commonly

known as the "Orange Book," which is incorporated herein by reference, as amended

and supplemented. The Orange Book can be obtained by contacting the

Superintendent of Documents, Government Printing Office, PO Box 371954,

Pittsburgh, PA 15250-7954, (202) 512-1800 or toll free (866) 512-1800, and is

available online at http://www.fda.gov/cder/orange/default.htm

and at

http://www.fda.gov/cder/ob/default.htm, and the lists of “Licensed Biological Products

with Reference Product Exclusivity and Biosimilarity or Interchangeability

Evaluations,” commonly known as the “Purple Book,” which is incorporated herein by

reference, as amended and supplemented. The Purple Book can be found online at

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedand

Approved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars;

13)

Assorted stock of prescription containers and child safety closures or caps that meet

the standards on light resistance, tightness, and water vapor permeation of Chapter

661 and moisture permeability of Chapter 671 of the United States

Pharmacopoeia/National Formulary, 2014 edition, which are both incorporated herein

by reference, as amended and supplemented, and are available for purchase at the

United States Pharmacopeia/National Formulary website at www.usp.org; and

14)

Copies of, or access to, current State statutes and rules relating to the practice of

pharmacy.

b) All prescription areas where non-sterile compounding is performed shall contain the

following minimum equipment and supplies, which shall be stored, so as to be readily

accessible:

Class A prescription balance with a complete set of metric weights or equivalent

electronic weighing device;

A glass mortar and pestle;

Glass funnels;

Stirring rods; and

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Ointment tile or parchment paper;

c) The prescription area and all related equipment and supplies shall be kept in a clean,

orderly and sanitary condition at all times.

13:39-5.9 PRESCRIPTION BALANCES, SCALES, WEIGHTS AND AUTOMATIC

COUNTING DEVICE

a) All pharmacies shall have all balances, scales, weights and automatic counting devices

inspected every 12 months by the Department of Weights and Measures of the

municipality or county in which the pharmacy is located, and such balances, scales,

weights and automatic counting devices shall be properly sealed by the applicable

authority.

b) Counting trays or counting devices that meet the requirements of (a) above shall be used

to count oral, solid drugs or medications.

13:39-5.10 RESTRICTION ON STORAGE OF PRESCRIPTION LEGEND DRUGS AND

CONTROLLED DANGEROUS SUBSTANCES

a) Prescription legend drugs, devices and controlled dangerous substances shall not be

stored in the pharmacy or pharmacy department in such a manner as to be accessible to

the public.

b) Prescription legend drugs, devices and controlled dangerous substances shall be stored

only in areas of the premises that are part of the pharmacy or pharmacy department,

except that in a health care facility, prescription legend drugs, devices and controlled

dangerous substances shall be stored consistent with the requirements of N.J.A.C.

13:39-9.23.

c) Prescription legend drugs, devices and controlled dangerous substances that are

received during hours the pharmacy or pharmacy department is closed shall be stored

consistent with the requirements of N.J.A.C. 13:39-4.15(b)3.

13:39-5.11 CONTROL AND MONITORING OF TEMPERATURE OF PRESCRIPTION

DRUGS AND CHEMICALS

a) All prescription drugs and chemicals shall be stored, filled, dispensed, transported,

and/or delivered to the patient, agent of the patient, or facility or healthcare provider

providing care to the patient to assure and maintain the integrity and stability of the

prescription drug or chemical at temperatures as specified by the drug manufacturer. If

the drug manufacturer has not specified the appropriate temperature, the prescription

drug or chemical shall be maintained at a temperature maintained thermostatically

between 20 and 25 degrees Celsius (68 and 77 degrees Fahrenheit).

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A pharmacy shall monitor and record the temperature of the pharmacy permitted area

and refrigerator and, if applicable, freezer, no less than twice daily with an interval of

at least eight hours.

i) Appropriate manual, electromechanical, or electronic temperature recording

equipment and/or logs shall be utilized to document proper storage of prescription

drugs and chemicals.

ii) A pharmacy shall maintain documentation of the recorded temperatures for two

years.

iii) A pharmacy shall calibrate thermometers or temperature monitoring devices at

predetermined intervals according to the manufacturer specifications.

A pharmacy that delivers a filled prescription drug or chemical to the patient, agent of

the patient, or facility or healthcare provider providing care to the patient by any

method, except when picked up directly from the pharmacy by the patient or his or

her authorized agent, shall, in the professional judgment of the pharmacist, and in

accordance with the pharmacy’s policies and procedures as set forth in (d) below,

use adequate methods to ensure temperature controlled conditions are maintained

during facility storage, transportation, and delivery.

i) To ensure that temperature control is maintained during delivery, the shipping

processes may include the use of appropriate packaging material or devices

according to information provided by the manufacturer, Chapter 1079 of USP,

other learned treatises, or expert qualification analysis.

ii) When packaging material or devices are used to maintain temperature control

during delivery, the contents of the package shall include instructions to the

recipient how to easily detect improper storage or temperature variation, and

instructions how to report the storage or temperature excursion to the pharmacy.

b) The temperature in a refrigerator and, if applicable, freezer that are used to store

prescription drugs or chemicals must be maintained according to USP standards and

guidelines.

c) The pharmacist-in-charge is responsible for ensuring proper temperature controls for all

prescription drugs and chemicals in the pharmacy permitted area and all prescription

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drugs and chemicals that are shipped, mailed, distributed, or otherwise delivered from

the pharmacy.

d) The pharmacist-in-charge shall develop and maintain written policies and procedures to

ensure the proper storage in the pharmacy permitted area of all prescription drugs and

chemicals, and the proper storage when prescription drugs or chemicals are delivered

from the pharmacy to the patient, agent of the patient, or facility or healthcare provider

providing care. The written policies and procedures shall include, at a minimum, the

following:

Monitoring and recording the temperature of the pharmacy permitted area and

refrigerator and, if applicable, freezer consistent with the requirements of this section;

Maintaining documentation of the recorded temperatures consistent with the

requirements of this section;

Actions to be taken in the event of temperature excursions include, but are not limited

to: notification of appropriate personnel, investigation of all temperature excursions,

inspection and disposal, as applicable, of the stock in question, and corrective

actions;

i. For purposes of this paragraph, a “temperature excursion” means any deviation

from the manufacturer’s specifications or, in the absence of manufacturer

specifications, applicable USP standards.

Calibrating thermometers or temperature monitoring devices consistent with the

requirements of this section;

Actions to be taken in the event that the prescription drugs and chemicals do not

arrive at their destination in a timely manner or when there is evidence that the

integrity of a drug was compromised during shipment or delivery; and

Training of all personnel who handle, or are responsible for overseeing the handling

of, prescription drugs and chemicals to ensure the appropriate storage and delivery

of all prescription drugs and chemicals, including refrigerated and frozen

pharmaceuticals.

e) In the event of a temperature excursion, as defined in (d)3i above, at a permitted

pharmacy practice site lasting 24 hours or more, the pharmacist-in-charge shall immediately

notify the Board. Notification shall be made in a manner such that notice is received by the

Board within 48 hours of becoming aware of the temperature excursion.

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f) In the event of a temperature excursion, as defined in (d)3i above, lasting 72 hours or

more, a pharmacist shall not dispense any prescription drug or chemical unless the

pharmacist verifies with the manufacturer of the prescription drug or chemical that as a

result of the temperature excursion, the drug or chemical has not been adulterated, is

safe and efficacious, and its stability has not been adversely affected.

13:39-5.12 (RESERVED)

13:39-5.13 PRESCRIPTION DRUG RETAIL PRICE LIST

a) A pharmacy shall comply with all requirements imposed by, and all requests for

information from, the Division of Consumer Affairs concerning prescription drug retail

price lists as provided in N.J.A.C. 13:45A-32.1.

b) Failure on the part of a pharmacy to comply with the requirements of N.J.A.C. 13:45A-

32.1 may subject the permit holder and/or the pharmacist in charge to disciplinary action

pursuant to N.J.S.A. 45:1-21 et seq.

SUBCHAPTER 6.

PHARMACIST-IN-CHARGE; PHARMACY PERSONNEL

13:39-6.1 PURPOSE AND SCOPE

The rules in this subchapter shall apply to all pharmacies and pharmacy departments in the

State. For purposes of this subchapter, "pharmacy" means a retail pharmacy or a retail

pharmacy department, an institutional pharmacy or a nuclear pharmacy.

13:39-6.2 PHARMACIST-IN-CHARGE

a) Every pharmacy shall name a pharmacist whose license is in good standing in New

Jersey as the pharmacist-in-charge of the pharmacy. No pharmacy shall operate without

a pharmacist-in-charge for longer than 30 days.

b) Whenever the pharmacist-in-charge is absent from the pharmacy for more than 30 days,

the pharmacist-in-charge and the permit holder shall notify the Board of the name of the

pharmacist who shall act as the interim pharmacist-in-charge.

c) A pharmacist shall not assume the responsibilities of a pharmacist-in-charge of more

than one pharmacy or pharmacy department simultaneously, except as provided in (c)1

below.

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If an area within a health care facility is permitted as both an institutional pharmacy

and a retail pharmacy, the health care facility may employ one individual to act as the

pharmacist-in-charge for both the institutional pharmacy and the retail pharmacy.

d) Whenever there is a change of a pharmacist-in-charge of a pharmacy, an inventory of all

controlled dangerous substances as defined in N.J.A.C. 13:45H-10.1 shall be performed

by both the outgoing and incoming pharmacist-in-charge consistent with the

requirements of N.J.A.C. 13:45H-5.4 and 5.5.

If the outgoing pharmacist-in-charge is unable to perform the inventory required in

section (d) above, the pharmacy permit holder shall designate an alternative

pharmacist, other than the incoming pharmacist-in-charge, to perform the inventory

and shall submit to the Board a documented explanation for choosing an alternate

pharmacist.

e) Whenever a pharmacist assumes or terminates the duties as a pharmacist-in-charge of a

pharmacy, both the outgoing and incoming pharmacist-in-charge and the permit holder

shall so advise the Board in writing within 30 days by completing a form provided by the

Board.

f) A pharmacist-in-charge shall be a full-time employee, employed for a minimum of 35

hours per week and shall be physically present in the pharmacy or pharmacy department

for that amount of time necessary to supervise and ensure that:

The pharmacy is staffed by sufficient, competent personnel in keeping with the size,

scope and complexity of the pharmaceutical services provided by the pharmacy;

Accurate records of all prescription medication received and dispensed are

maintained;

Policies are in place regarding accurate dispensing and labeling of prescriptions and

that such policies are followed;

Security of the prescription area and its contents are maintained at all times

consistent with the requirements set forth in N.J.A.C. 13:39-4.15;

Only pharmacists and interns or externs under immediate personal supervision

provide professional consultation with patients and physicians;

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Only pharmacists, interns or externs accept telephone prescriptions and only

pharmacists, interns or externs, or pharmacy technicians consistent with the

requirements of N.J.A.C. 13:39-6.6(b), accept renewal authorizations;

No misbranded, deteriorated, adulterated, improperly stored or outdated drugs or any

drugs marked "sample" or with any like designation or meaning are dispensed or

present in the active stock in the pharmacy;

The prescription area is maintained in an orderly and sanitary manner;

There are written policies and procedures to ensure the proper storage and delivery

of all prescription drugs and chemicals consistent with the requirements set forth in

N.J.A.C. 13:39-5.11 and that such policies and procedures are followed; and

10)

The pharmacy and all pharmacy personnel provide pharmaceutical services in

accordance with acceptable professional standards and comply with all Federal and

State statutes, rules and regulations governing the practice of pharmacy.

g) The pharmacist-in-charge is responsible for the accuracy and completeness of the

biennial inventory of all controlled dangerous substances required under N.J.A.C.

13:45H-5.5, and shall sign and date the biennial inventory upon its completion. This

requirement applies whether the inventory is conducted by the pharmacist-in-charge or

another licensed pharmacist.

13:39-6.3 IDENTIFICATION TAG

All personnel working at any pharmacy practice site, except personnel engaging in the

compounding of sterile preparations consistent with the requirements of N.J.A.C. 13:39-11, shall

wear an identification tag, which shall include at least the person's first name, first initial of their

last name, and job title. The identification tag of any employee in training shall reflect the status

of the employee as a trainee.

13:39-6.4 MEAL OR RESTROOM BREAKS

a) A sole pharmacist on duty may take restroom breaks and 30-minute meal breaks while

working in a pharmacy consistent with the following requirements:

The pharmacist shall remain in the pharmacy or, in the case of a pharmacy

department, in the pharmacy department building, and shall be accessible for

emergencies or for counseling, if requested;

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The pharmacy shall remain open during the restroom or meal breaks, provided a

pharmacy employee remains present in the pharmacy, for patient related services,

which include, but are not limited to, the following:

i) The receipt of new written prescriptions; and

ii) The dispensing of prescription medications which have been checked by the

pharmacist; and

A sign shall be posted in the prescription dispensing area stating "Pharmacist on

break, but available for emergencies and counseling."

13:39-6.5 PRESCRIPTION HANDLING BY PHARMACY EXTERNS, PHARMACY

INTERNS, PHARMACY TECHNICIANS, PHARMACY TECHNICIAN APPLICANTS, OR

UNLICENSED OR UNREGISTERED PERSONNEL

a) A pharmacy intern, pharmacy extern, pharmacy technician, or pharmacy technician

applicant in any pharmacy may perform the component functions of prescription handling

described in N.J.A.C. 13:39-4.19, consistent with the requirements of this chapter. All steps

performed by a pharmacy technician, pharmacy technician applicant, pharmacy intern, or

pharmacy extern shall be documented in the pharmacy audit trail consistent with the

requirements of N.J.A.C. 13:39-7.6.

b) Pharmacy interns and pharmacy externs may assist the pharmacist in performing the

following tasks:

Retrieval of prescription files, patient files, and profiles and other such records

pertaining to the practice of pharmacy;

Data entry of prescription medication information, including the original or refill date

of the prescription, the number or designation identifying the prescription, the

practitioner’s information, and the name, strength, and quantity of the prescribed

medication;

The collection of the following demographic information for the patient profile: the

name, address, and telephone number of the patient; the patient’s age, date of birth;

or age group (infant, child, adult); gender; any allergies and idiosyncrasies of the

patient; and any medical conditions that may relate to drug utilization;

Transcription of scanned prescription or medication order information into the patient

record;

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Label preparation;

The counting, weighing, measuring, pouring, and compounding of prescription

medication or stock legend drugs and controlled substances, including the filling of

an automated medication system; and

Accepting authorization from a patient for a prescription refill, or from a practitioner or

his or her agent for a prescription renewal, provided that the prescription remains

unchanged.

c) The collection of the demographic information under (b)3 above may be performed by

unlicensed or unregistered personnel.

13:39-6.6 PHARMACY TECHNICIAN REGISTRATION AND PHARMACY TECHNICIAN

APPLICANTS

a) A person wishing to be registered with the Board as a pharmacy technician shall:

Be 18 years of age or older;

Possess a high school diploma or its equivalent;

Submit a certification attesting to the fact that he or she is proficient in written and

spoken English;

Apply to the Board for registration and submit the application fee set forth in N.J.A.C.

13:39-1.3;

Submit his or her name, address and fingerprints for purposes of a criminal history

background check pursuant to N.J.S.A. 45:1-28 et seq., (P.L. 2002, c. 104) to

determine whether criminal history record information exists which may disqualify the

applicant from being registered by the Board; and

Submit, as part of the application for registration, evidence of good moral character

which is an ongoing requirement for registration, and evidence that he or she:

i) Is not presently engaged in drug or alcohol use that is likely to impair the ability to

practice as a pharmacy technician with reasonable skill and safety. For purposes

of this section, the term "presently" means at the time of application or any time

within the previous 365 days;

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ii) Has not been convicted of violating any law of this State or any other state of the

United States relating to controlled dangerous substances or other habit-forming

drugs;

iii) Has not been convicted of violating any law relating to the practice of pharmacy;

iv) Has not been convicted of a crime involving moral turpitude; and

v) Has not had his or her authority to engage in the activity regulated by the Board

suspended or revoked as a result of any administrative or disciplinary

proceedings in this or any other jurisdiction which determined the applicant to be

in violation of any laws, rules or regulations pertaining to the practice of

pharmacy, and that the applicant is not currently under suspension or revocation.

b) A pharmacy shall only employ a person registered with the Board as a pharmacy

technician pursuant to (a) above, or a pharmacy technician applicant, consistent with (c)

below, to perform pharmacy technician functions.

c) Any person who is hired as a pharmacy technician who is not registered with the Board

shall be designated a pharmacy technician applicant. A person may only be considered a

pharmacy technician applicant one time and only for a maximum of 180 consecutive

days. During the first 10 days of employment, the pharmacy technician applicant shall file

an application with the Board to begin the pharmacy technician registration process. The

applicant shall retain proof of filing the application until he or she receives his or her

registration. If at the conclusion of the 180-day period, the pharmacy technician applicant

has not completed the pharmacy technician registration process, consistent with (a)

above, the applicant shall cease performing pharmacy technician functions in the

pharmacy.

d) If an applicant for registration as a pharmacy technician is being investigated for any

alleged violation of the New Jersey Pharmacy Practice Act, N.J.S.A. 45:14-40 et seq., or

the pharmacy laws, rules or regulations of any other jurisdiction, the Board in its

discretion may deny the applicant the opportunity to register as a pharmacy technician.

e) A pharmacy shall not employ as a pharmacy technician applicant any person who was

previously employed as a pharmacy technician applicant at a pharmacy in the State and

who failed to complete the pharmacy technician registration process or any person who

has been the subject of disciplinary action by the Board.

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13:39-6.7 AUTHORIZATION TO PRACTICE AS A PHARMACY TECHNICIAN;

DISPLAY OF REGISTRATION

a) An applicant for registration as a pharmacy technician who has successfully satisfied all

Board requirements for registration and has been approved by the Board to be registered

shall, upon payment of the initial registration fee set forth in N.J.A.C. 13:39-1.3, receive

an authorization signed by the Executive Director of the Board granting the applicant the

right to practice as a pharmacy technician in the State of New Jersey until such time as

an initial registration may be issued. The registrant shall maintain such authorization on

his or her person at all times while engaging in the practice of pharmacy as a pharmacy

technician until the initial registration is issued.

b) Upon issuance, the current biennial renewal registration shall be conspicuously

displayed in view of the public in the registered pharmacy technician's principal place of

employment.

c) A registered pharmacy technician who is employed by more than one pharmacy in the

State shall maintain the wallet-sized registration issued by the Board on his or her person

when he or she is working at a location where his or her current biennial renewal

registration is not on display.

13:39-6.8 REPLACEMENT OF TECHNICIAN REGISTRATION

A replacement initial registration or renewal registration shall be issued by the Board upon

payment of a fee as prescribed in N.J.A.C. 13:39-1.3 and upon submission of proof of the

applicant's identity and reasonable proof of the loss or destruction of the initial registration or

renewal registration, or upon return of the damaged initial registration or renewal registration to

the Board.

13:39-6.9 TECHNICIAN CHANGE OF NAME

If a registered pharmacy technician legally changes the name under which he or she has

been practicing as a pharmacy technician, the pharmacy technician shall notify the Board within

30 days of such change. The registered pharmacy technician shall submit original proof of the

change of name or a certified copy of the court order or marriage certificate which shall be

retained by the Board. When a replacement registration is issued, the initial registration shall be

returned for cancellation and the pharmacy technician shall remit the required fee as prescribed

in N.J.A.C. 13:39-1.3.

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13:39-6.10 TECHNICIAN CHANGE OF ADDRESS OF RECORD; SERVICE OF

PROCESS

a) A registered pharmacy technician shall notify the Board in writing of any change in his or

her address of record within 30 days of such change.

b) Failure to notify the Board of any change in a registered pharmacy technician's address

of record pursuant to (a) above may result in disciplinary action in accordance with

N.J.S.A. 45:1-21(h) and N.J.A.C. 13:45C-1.3, and the imposition of penalties set forth in

N.J.S.A. 45:1-25.

c) Service of any administrative complaint or other Board-initiated process at a registered

pharmacy technician's address of record shall be deemed adequate notice for the

purposes of N.J.A.C. 1:1-7.1 and the commencement of any disciplinary proceedings.

13:39-6.11 VERIFICATION OF TECHNICIAN REGISTRATION

A verification that the registration of a pharmacy technician is in good standing shall be

supplied by the Board upon written request and upon payment of the fee set forth in N.J.A.C.

13:39-1.3.

13:39-6.12 REPRODUCTION OF TECHNICIAN REGISTRATION PROHIBITED

The initial registration, biennial registration or wallet-sized registration issued by the Board to

any pharmacy technician shall not be reprinted, photographed, photostated, duplicated or

reproduced by any other means either in whole or in part, except as provided in N.J.A.C. 13:39-

6.8.

13:39-6.13 PHARMACY TECHNICIAN REGISTRATION RENEWAL

a) The Board shall send a notice of renewal to each pharmacy technician registrant, at least

60 days prior to the expiration of the registration. The notice of renewal shall explain

inactive renewal and advise the registrant of the option to renew as inactive. If the notice

to renew is not sent 60 days prior to the expiration date, no monetary penalties or fines

shall apply to the holder for failure to renew provided that the registration is renewed

within 60 days from the date the notice is sent or within 30 days following the date of

registration expiration, whichever is later.

b) A pharmacy technician shall renew his or her registration for a period of two years from

the last expiration date. The pharmacy technician shall submit a renewal application to

the Board, along with the renewal fee set forth in N.J.A.C. 13:39-1.3, prior to the date of

registration expiration.

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c) A pharmacy technician may renew his or her registration by choosing inactive status. A

pharmacy technician electing to renew his or her registration as inactive shall not perform

the functions of a pharmacy technician, or hold himself or herself out as eligible to

perform the functions of a pharmacy technician, in New Jersey until such time as the

registration is returned to active status.

d) If a pharmacy technician does not renew the registration prior to its expiration date, the

pharmacy technician may renew the registration within 30 days of its expiration by

submitting a renewal application, a renewal fee, and a late fee as set forth in N.J.A.C.

13:39-1.3. During this 30-day period, the registration shall be valid and the pharmacy

technician shall not be deemed practicing without a registration.

e) A pharmacy technician who fails to submit a renewal application within 30 days of

registration expiration shall have his or her registration suspended without a hearing.

f) A pharmacy technician who continues to perform the functions of a pharmacy technician

with a suspended registration shall be deemed to be engaging in unauthorized practice

and shall be subject to action consistent with N.J.S.A. 45:1-14 et seq., even if no notice

of suspension has been provided to the individual.

13:39-6.14 PHARMACY TECHNICIAN REGISTRATION REACTIVATION

a) A pharmacy technician who holds an inactive registration pursuant to N.J.A.C. 13:39-

6.13(c) may apply to the Board for reactivation of the inactive registration. A pharmacy

technician seeking reactivation of an inactive registration shall submit:

A renewal application;

A certification of employment listing each job held during the period the registration

was inactive, which includes the name, address, and telephone number of each

employer; and

The renewal fee for the biennial period for which reactivation is sought as set forth in

N.J.A.C. 13:39-1.3.

i) If the renewal application is sent during the first year of the biennial period, the

applicant shall submit the renewal fee as set forth in N.J.A.C. 13:39-1.3.

ii) If the renewal application is sent during the second year of the biennial period,

the applicant shall submit one-half of the renewal fee as set forth in N.J.A.C.

13:39-1.3.

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b) If a Board review of an application establishes a basis for concluding that there may be

practice deficiencies in need of remediation prior to reactivation, the Board may require

the applicant to submit to and successfully pass an examination or an assessment of

skills, a refresher course, or other requirements as determined by the Board prior to

reactivation of the registration. If that examination or assessment identifies deficiencies

or educational needs, the Board may require the applicant as a condition of reactivation

of the registration to take and successfully complete any education or training or to

submit to any supervision, monitoring, or limitations as the Board determines is

necessary to assure that the applicant practices with reasonable skill and safety. The

Board, in its discretion, may restore the registration subject to the applicant’s completion

of the training within a period of time prescribed by the Board following the restoration of

the registration. In making its determination whether there are practice deficiencies

requiring remediation, the Board shall consider the following non-exhaustive issues:

Length of time registration was inactive;

Employment history;

Professional history;

Disciplinary history and any action taken against the applicant’s license or

registration by any licensing board;

Actions affecting the applicant’s privileges taken by any institution, organization, or

employer related to the practice of a pharmacy technician or other professional or

occupational practice in New Jersey, any other state, the District of Columbia, or in

any other jurisdiction;

Pending proceedings against a professional or occupational license issued to the

pharmacy technician by a professional board in New Jersey, any other state, the

District of Columbia, or in any other jurisdiction; and

Civil litigation related to the practice of a pharmacy technician or other professional or

occupational practice in New Jersey, any other state, the District of Columbia, or in

any other jurisdiction.

13:39-6.14A PHARMACY TECHNICIAN REGISTRATION REINSTATEMENT FROM

ADMINISTRATIVE AND DISCIPLINARY SUSPENSIONS

a) A pharmacy technician who has had his or her registration administratively suspended

pursuant to N.J.A.C. 13:39-6.13(e) may apply to the Board for reinstatement. A

pharmacy technician applying for reinstatement shall submit:

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A reinstatement application;

A certification of employment listing each job held during the period of suspended

registration, which includes the names, addresses, and telephone number of each

employer;

The renewal fee for the biennial period for which reinstatement is sought;

The past due renewal fee for the biennial period immediately preceding the renewal

period for which reinstatement is sought; and

The reinstatement fee set forth in N.J.A.C. 13:39-1.3.

b) If a Board review of an application establishes a basis for concluding that there may be

practice deficiencies in need of remediation prior to reinstatement, the Board may require

the applicant to submit to and successfully pass an examination or an assessment of

skills, a refresher course, or other requirements as determined by the Board prior to

reinstatement of the registration. If that examination or assessment identifies

deficiencies or educational needs, the Board may require the applicant as a condition of

reinstatement of the registration to take and successfully complete any education or

training or to submit to any supervision, monitoring, or limitations as the Board

determines is necessary to assure that the applicant practices with reasonable skill and

safety. The Board, in its discretion, may restore the registration subject to the applicant’s

completion of the training within a period of time prescribed by the Board following the

restoration of the registration. In making its determination whether there are practice

deficiencies requiring remediation, the Board shall consider the following non-exhaustive

issues:

Length of time registration was suspended;

Employment history;

Professional history;

Disciplinary history and any action taken against the applicant’s license or

registration by any licensing board;

Actions affecting the applicant’s privileges taken by any institution, organization, or

employer related to the practice of a pharmacy technician or other professional or

occupational practice in New Jersey, any other state, the District of Columbia, or in

any other jurisdiction;

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Pending proceedings against a professional or occupational license, registration, or

certificate issued to the pharmacy technician by a professional board in New Jersey,

any other state, the District of Columbia, or in any other jurisdiction; and

Civil litigation related to the practice of a pharmacy technician or other professional or

occupational practice in New Jersey, any other state, the District of Columbia, or in

any other jurisdiction.

c) A pharmacy technician who has had his or her registration suspended pursuant to

disciplinary action taken by the Board may apply to the Board for reinstatement of his or her

registration at the conclusion of the suspension period. A pharmacy technician applying for

reinstatement from a disciplinary suspension shall submit:

A reinstatement application, including an affidavit of employment listing each job held

during the period of registration suspension, including the names, addresses, and

telephone numbers of each employer;

A reinstatement fee set forth in N.J.A.C. 13:39-1.3;

The applicable renewal fee(s) set forth in N.J.A.C. 13:39-1.3; and

Evidence of having met all conditions imposed by the Board pursuant to the

disciplinary and/or reinstatement order(s).

13:39-6.15 PHARMACY TECHNICIAN DUTIES AND PHARMACIST-TECHNICIAN

RATIOS

a) Pharmacy technicians and pharmacy technician applicants may assist the pharmacist in

performing the following tasks:

Retrieval of prescription files, patient files and profiles and other such records

pertaining to the practice of pharmacy;

Data entry of prescription medication information, including the original or refill date

of the prescription, the number or designation identifying the prescription, the

practitioner’s information, and the name, strength, and quantity of the prescribed

medication;

The collection of the following demographic information for the patient profile: the

name, address, and telephone number of the patient; the patient’s age, date of birth;

or age group (infant, child, adult); gender; any allergies and idiosyncrasies of the

patient; and any medical conditions that may relate to drug utilization;

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Transcription of scanned prescription or medication order information into the patient

record;

Label preparation;

The counting, weighing, measuring, pouring and compounding of prescription

medication or stock legend drugs and controlled substances, including the filling of

an automated medication system; and

Accepting authorization from a patient for a prescription refill, or from a practitioner or

his or her agent for a prescription renewal, provided that the prescription remains

unchanged, consistent with (a)7i below:

i) The pharmacy technician or pharmacy technician applicant shall identify himself

or herself as a pharmacy technician when accepting authorization from a

practitioner or his or her agent. For purposes of this section, "prescription refill"

means the dispensing of medications pursuant to a practitioner's authorization

provided on the original prescription. For purposes of this section, "prescription

renewal" means the dispensing of medications pursuant to a practitioner's

authorization to fill an existing prescription that has no refills remaining.

b) Pharmacy technicians and pharmacy technician applicants shall not:

Receive new verbal prescriptions;

Interpret a prescription or medication order for therapeutic acceptability and

appropriateness;

Verify dosage and directions;

Engage in prospective drug review;

Provide patient counseling;

Monitor prescription usage;

Override computer alerts without first notifying the pharmacist;

Transfer prescriptions from one pharmacy to another pharmacy; or

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Violate patient confidentiality.

c) A pharmacy shall require all pharmacy technicians and pharmacy technician applicants

employed by the pharmacy to sign a patient confidentiality statement. Such statements

shall be maintained on-site by the pharmacy.

d) Except as provided in (e) below, a pharmacist shall not supervise more than two

pharmacy technicians at any given time. The pharmacist shall provide immediate

personal supervision, as defined in N.J.A.C. 13:39-1.2, of all pharmacy technicians he or

she supervises. Those personnel who do computer processing of prescriptions are to be

included in the 1 to 2 ratio. A registered pharmacy technician or a pharmacy technician

applicant who is receiving in-service training, which shall not exceed 210 days, shall be

excluded from the 1 to 2 ratio during such training. A pharmacist shall not supervise

more than two persons receiving in-service training at the same time.

e) A pharmacy that employs a pharmacist to pharmacy technician ratio greater than 1:2

shall:

Establish written job descriptions, task protocols, and policies and procedures that

pertain to the duties performed by the pharmacy technicians;

Ensure and document that all pharmacy technicians who are working when the ratio

exceeds 1:2 have:

i) Passed the Pharmacy Technician Certification Board's Pharmacy Technician

Certification Examination and have fulfilled the requirements to maintain this

status;

ii) Passed a Board-approved certification program and have fulfilled the

requirements to maintain this status; or

iii) Completed a program that includes a testing component, which has been

approved by the Board as satisfying the criteria set forth in (f) below. Completion

of a program with a Board-approved testing component shall qualify the

pharmacy technician to work only for the specific pharmacy and/or corporation for

which the pharmacy technician was employed when the training was obtained. If

the pharmacy technician becomes employed by another pharmacy and/or

corporation, the pharmacy technician shall be required to complete the new

employer's training program;

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Ensure that all pharmacy technicians are knowledgeable in the established job

descriptions, task protocols, and policies and procedures in the pharmacy setting in

which the technicians are to perform their duties;

Ensure that the duties assigned to any pharmacy technician do not exceed the

established job descriptions, task protocols and policies and procedures, nor involve

any of the prohibited tasks in (b) above;

Ensure that all pharmacy technicians receive in-service training before the pharmacy

technicians assume their responsibilities and maintain documentation thereof. A

registered pharmacy technician or a pharmacy technician applicant who is receiving

in-service training, which shall not exceed 210 days, shall be excluded from the 1 to

2 ratio during such training. A pharmacist shall not supervise more than two persons

receiving in-service training at the same time;

Provide immediate personal supervision as defined in N.J.A.C. 13:39-1.2; and

Provide the Board, upon request, with a copy of the established job descriptions, task

protocols, and policies and procedures for all pharmacy technician duties.

f) If the pharmacist to pharmacy technician ratio exceeds 1:2, the pharmacy shall maintain

a policy and procedure manual with regard to pharmacy technicians, which shall include

the following:

Supervision by a pharmacist;

Confidentiality safeguards of patient information;

Minimum qualifications;

Documentation of in-service education and/or ongoing training and demonstration of

competency, specific to practice site and job function;

General duties and responsibilities of pharmacy technicians;

Retrieval of prescription files, patient files, patient profile information and other

records pertaining to the practice of pharmacy;

All functions related to prescription processing;

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All functions related to prescription legend drug and controlled substance ordering

and inventory control;

Prescription refill and renewal authorization;

10)

Procedures dealing with documentation and records required for controlled drug

substance and prescription legend drugs;

11)

Procedures dealing with medication errors, including classification of medication

errors;

12)

Pharmacy technician functions related to automated systems;

13)

Functions that may not be performed by pharmacy technicians, including at a

minimum those functions listed in (b) above; and

14)

A form signed by the pharmacy technician which verifies that the manual has been

reviewed by the technician.

g) The pharmacist-in-charge shall review at least every two years and, if necessary, amend

the policy and procedure manual. Documentation of the review shall be made available

to the Board upon request.

h) When pharmacy technicians and pharmacy technician applicants are engaged in any

permitted activities, the pharmacist(s) shall be responsible for all the activities of the

pharmacy technicians and the pharmacy technician applicants.

SUBCHAPTER 7.

DRUG DISPENSING AND PRESCRIPTION RECORDS

13:39-7.1 VALID PRESCRIPTIONS

a) A pharmacist shall only fill a prescription issued by a practitioner licensed to issue

prescriptions in New Jersey and practicing in New Jersey if the prescription is on a New

Jersey Uniform Prescription Blank pursuant to N.J.S.A. 45:14-55 and N.J.A.C. 13:45A-

27, except as provided in N.J.A.C. 13:39-7.10 and 7.11.

b) A pharmacist shall fill a prescription issued by a practitioner authorized to issue

prescriptions in another state, territory or possession of the United States, including

prescriptions issued at facilities within or outside of New Jersey that are regulated by the

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United States Department of Veterans Affairs and/or the Department of Defense. Such

prescriptions shall be filled pursuant to New Jersey law. Such prescriptions shall not be

required to be issued on a New Jersey Uniform Prescription Blank.

c) Prescriptions, other than those listed in (a) and (b) above, shall not be filled by a

pharmacy in New Jersey.

13:39-7.2 LACK OF INFORMATION ON ORIGINAL PRESCRIPTION

a) If a practitioner fails to include on the original prescription any information that he or she

is required to include pursuant to rules governing the practitioner's professional practice,

including New Jersey Uniform Prescription Blanks rules set forth at N.J.A.C. 13:45A-27,

the pharmacist shall obtain such information.

If the practitioner has failed to include directions for use and the practitioner cannot

be contacted, the pharmacist shall indicate on the prescription label the words "use

as directed" or "as ordered by the physician" or similar words to the same effect.

b) All information required for a valid prescription shall be recorded on the prescription, or in

the patient profile record system maintained pursuant to N.J.A.C. 13:39-7.19, or in the

pharmacy's other manual or electronic files.

13:39-7.3 AUTHORIZATION FOR RENEWAL OF PRESCRIPTIONS; NEW

PRESCRIPTIONS

a) A prescription for medication or devices, which pursuant to State or Federal law may be

sold, dispensed or furnished only upon prescription, shall not be renewed without specific

authorization of the practitioner or the practitioner's authorized agent, and the

prescription may not be filled or refilled after one year from the date the original

prescription was issued. A pharmacist obtaining authorization from a practitioner's

authorized agent shall document the name and title of the agent.

Prescriptions marked "PRN" or other letters or words meaning refill as needed shall

not be renewed beyond one year past the date the original prescription was issued.

b) When the renewals listed on the original prescription have been depleted, no additional

renewals may be added to the original prescription. For additional dispensing, a new

prescription must be authorized by the practitioner.

c) Prescription information obtained from a practitioner shall be documented at the time of

receipt as a new prescription in hard copy form or by direct entry into the electronic

prescription records system.

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13:39-7.4 EMERGENCY DISPENSING

a) Except as provided in (b) below, in the absence of a current, valid prescription, a

pharmacist may dispense an emergency supply (no more than a 72-hour quantity) of a

chronic maintenance drug or device if, in his or her professional judgment, refusal would

endanger the health or welfare of the patient, provided the following conditions are

satisfied:

The pharmacist first ascertains to the best of his or her ability, by direct

communication with the patient or caregiver, that such a medication or device was

prescribed for that patient by order of a practitioner. The pharmacist shall require the

patient or caregiver to provide suitable identification. Such communication shall be

documented in the patient profile record system maintained pursuant to N.J.A.C.

13:39-7.19 or in the pharmacy's other manual or electronic files; and

The pharmacist documents the dispensing of the emergency supply in the

prescription record system.

b) A pharmacist may dispense an emergency supply of a Schedule II controlled dangerous

substance in the absence of a current, valid prescription upon receipt of oral

authorization from a practitioner as provided under Federal law pursuant to 21 CFR

1306.11, consistent with the requirements of N.J.A.C. 13:45H-7.8.

13:39-7.5 APPROVAL OF FDA NECESSARY

a) No drug or medicine other than a compounded prescription order, consistent with (c)

below, shall be sold or dispensed in any pharmacy within the State of New Jersey until

such drug or medicine has received New Drug Application (NDA), Abbreviated New Drug

Application (ANDA), Investigational New Drug Application (INDA) or other Federal Food

and Drug Administration (FDA) approval, where required.

b) The storage, labeling and dispensing of all Investigational New Drugs shall be a

pharmaceutical service provided in cooperation with, and in support of the principal

investigator. Under these parameters the dispensing of such drugs shall not be

construed to be a violation of (a) above. A pharmacy participating in experimental

research shall comply with Federal Department of Health and Human Services

regulations set forth at 45 CFR Part 46, Protection of Human Subjects of Research,

incorporated by reference herein, as amended and supplemented and with the Rowan

University Guidance on Human Subjects Research, which is incorporated herein by

reference, as amended and supplemented, and which is available at

http://www.rowan.edu/som/hsp/guidance/index.html

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c) No pharmacy or pharmacist shall compound products prohibited by the FDA or use

ingredients that are restricted by the FDA.

13:39-7.6 REQUIRED RECORDS AND DOCUMENTS

a) A pharmacy shall maintain an audit trail that records and documents the unique and

secure user identifier(s) of the pharmacist(s), pharmacy technician(s), intern(s), or

extern(s) performing the component functions of intake, processing, fulfillment, and

dispensing of prescriptions as defined in N.J.A.C. 13:39-4.19, which are required to be

performed by a pharmacist, pharmacy technician, intern, or extern pursuant to the

requirements of this chapter. The collection of demographic information for the patient

profile as provided for in N.J.A.C. 13:39-6.15(a)3 is not required to be, but may be,

recorded in the audit trail.

b) All entries to the audit trail made by a pharmacy technician, intern, or extern shall be

reviewed and approved by the pharmacist. When more than one pharmacist is involved

in the component functions of prescription handling, each pharmacist shall be

responsible for the accuracy and appropriateness of each component function he or she

performed or reviewed and approved, and his or her unique and secure user identifier(s)

shall be recorded in the audit trail. Audit trail documentation shall be generated at the

time each component function(s) is performed.

c) Computer systems employed for audit trail documentation shall be designed to identify

and document the unique and secure identifier for all pharmacists, pharmacy technicians,

interns and externs who utilize the system. Computer systems that automatically

generate the unique and secure user identifier of a pharmacist, pharmacy technician,

intern or extern without requiring an entry by the responsible party are prohibited.

d) Appropriate documentation identifying the unique and secure user identifier of all

pharmacists, pharmacy technicians, interns and externs employed by the pharmacy shall

be maintained by the pharmacy for a period of not less than five years after the last date

of employment. If a pharmacy utilizes a manual system, appropriate documentation

identifying the handwritten initials with the handwritten signature and printed name of all

pharmacists, pharmacy technicians, interns and externs employed by the pharmacy shall

be maintained for a period of not less than five years after the last date of employment.

The oldest four years of record information shall be maintained in such a manner so as

to be retrievable and readable within two weeks. The most recent one year of a record

information shall be retrievable and readable within one business day. Records not

currently in use need not be stored in the pharmacy, but off-site facilities used to store

such records shall be secure.

e) All audit trail and prescription information shall be maintained or stored in original hard

copy form or in any other media that facilitates the reproduction of the original hard copy

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and shall be maintained for a period of not less than five years. The oldest four years of

record information shall be maintained in such a manner so as to be retrievable and

readable within two weeks. The most recent one year of a record information shall be

retrievable and readable within one business day. Records not currently in use need not

be stored in the pharmacy, but off-site facilities used to store such records shall be

secure. Patient records shall be kept confidential, but shall be made available to persons

authorized to inspect them under State and Federal statutes and regulations.

f) Notwithstanding the requirements of (d) above, a pharmacy shall maintain prescription

records for controlled dangerous substances as required by Federal law consistent with

the provisions of 21 CFR 1304.04.

13:39-7.7 COPIES OF PRESCRIPTIONS AND/OR PATIENT PROFILE

a) A pharmacy shall immediately comply with the patient's request for copies of

prescriptions and/or patient profile. Copies of prescriptions issued directly to the patient

shall state in letters at least equal in size to those describing the medication dispensed,

the underlined statement: "COPY—FOR INFORMATION ONLY." For purposes of this

section, for requests for prescriptions that are one year or less from the original date of

filling, “immediately” shall not exceed 24 hours. For all other prescriptions, “immediately”

shall not exceed 72 hours.

b) Presentation of a prescription marked "COPY—FOR INFORMATION ONLY" or a labeled

prescription container shall be for information purposes only and shall have no legal

status as a valid prescription order. The pharmacist in receipt of such copy or labeled

prescription container shall contact the prescribing practitioner for a new prescription or

the last dispensing pharmacy to transfer the prescription pursuant to N.J.A.C. 13:39-7.8.

13:39-7.8 TRANSFER OF PRESCRIPTIONS BETWEEN PHARMACIES

a) When a patient, the patient's caregiver, or a pharmacy acting on behalf of a patient or

caregiver requests the transfer of a valid prescription between pharmacies, a pharmacy,

the registered pharmacist-in-charge, and the pharmacist who receives the request for

transfer shall immediately comply with the patient's request. For purposes of this

section, “immediately” shall not exceed four hours.

b) Except as provided in (c) and (d) below, a prescription may be transferred between

pharmacies, consistent with this section, for one year from the date the prescription was

written, provided refills of the prescription are available.

c) A prescription for a Schedule II controlled substances may not be transferred.

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d) A prescription for a Schedule III, IV or V controlled substance may be transferred

between pharmacies pursuant to N.J.A.C. 13:45H-7.18. A prescription for a Schedule III,

IV or V controlled substance that has been transferred shall not be transferred a second

time. This prohibition shall not apply to the transfer of such prescriptions between

pharmacies engaged in central prescription handling pursuant to N.J.A.C. 13:39-4.18(e)

and to pharmacies that share a real-time, online database consistent with the

requirements of 21 CFR 1306.25.

e) A prescription may be transferred between pharmacies for the purpose of refill

dispensing by telephone, or by facsimile or electronic means as provided in N.J.A.C.

13:39-7.10 and 7.11, provided that:

The sending pharmacy invalidates the prescription on file as of the date the

prescription is transferred and records on the back of the invalidated prescription

order or in the electronic system the following:

i) That the prescription has been transferred and the date of transfer;

ii) The name and address or store identifier of the pharmacy to which the

prescription was transferred;

iii) The name or personal identifier of the pharmacist, intern or extern to whom the

prescription was transferred; and

iv) The initials or personal identifier of the pharmacist, intern, or extern issuing the

transferred prescription order;

The receiving pharmacy, upon receiving such prescription directly from another

pharmacy, records the following:

i) The name and address or store identifier and original prescription number of the

pharmacy from which the prescription was transferred;

ii) The name or personal identifier of the sending pharmacist, intern or extern;

iii) All information constituting a prescription order, as well as the following:

(1) Date of issuance of original prescription;

(2) Original number of refills authorized on original prescription;

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(3) Number of valid refills remaining; and

(4) Date the prescription was last filled; and

The pharmacist, intern, extern, or technician at the receiving pharmacy informs the

patient or caregiver that the original prescription has been cancelled at the sending

pharmacy.

13:39-7.9 FILING AND STORAGE OF CONTROLLED SUBSTANCE PRESCRIPTIONS

a) Prescriptions for all controlled substances listed in Schedule II shall be maintained in a

separate prescription file.

b) Prescriptions for all controlled substances listed in Schedules III, IV and V shall be

maintained in a separate prescription file for such controlled substances only or in such

form that they are readily retrievable from other prescription records of the pharmacy.

Prescriptions will be deemed readily retrievable if, at the time they are initially filed, the

face of the prescription is stamped in red ink in the lower right corner with the letter "C"

no less than one-inch high and filed either in the prescription file for controlled

substances listed in Schedule II or in the prescription file for non-controlled substances.

If a pharmacy employs an electronic recordkeeping system for prescriptions that permits

identification by prescription number and retrieval of original documents by the

practitioner's name, patient's name, drug dispensed and date filled, then the requirement

to mark the hard copy prescription with a red "C" shall be waived.

13:39-7.10 PRESCRIPTIONS TRANSMITTED BY FACSIMILE

a) A pharmacist may accept for dispensing a facsimile prescription, consistent with the

requirements of this section. For purposes of this section, "facsimile prescription" means

a prescription which is transmitted by a device which sends an exact image to the

receiver.

b) A pharmacist shall not fill a facsimile prescription transmitted by anyone other than a

practitioner authorized to prescribe medications pursuant to N.J.S.A. 45:14-40, or the

prescribing practitioner's authorized agent.

c) The facsimile machine used to receive prescriptions shall be located within the pharmacy

prescription area.

d) A facsimile prescription shall contain all information required to be included on a written

prescription pursuant to New Jersey State Board of Medical Examiners rule N.J.A.C.

13:35-7.2(d), except that an NJPB shall not be required for the prescription.

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e) The facsimile transmission of the prescription shall contain the following:

The identification number of the facsimile machine which is used to transmit the

prescription;

The date and time of the prescription transmission;

The name, address, telephone number and facsimile number of the pharmacy; and

If an authorized agent transmits the facsimile prescription, the full name and title of

the transmitting agent.

f) A pharmacist shall seek verbal verification of a facsimile prescription from the prescribing

practitioner whenever the pharmacist has reason to question the authenticity, accuracy

or appropriateness of the prescription. A pharmacist may accept verbal verification

regarding the authenticity or legibility of a facsimile prescription from a prescribing

practitioner's authorized agent. A pharmacist shall not fill a facsimile prescription where

there is a question regarding authenticity, accuracy or appropriateness if such

verification is not provided.

g) A pharmacist shall retain a printed copy of a facsimile prescription, or an electronic

reproduction of the facsimile prescription that is readily retrievable and printable, for a

minimum of five years. The printed copy shall be of non-fading legibility.

h) A pharmacist may fill a prescription for a Schedule II controlled substance transmitted by

facsimile provided that the original signed prescription is presented to the pharmacist

prior to the dispensing of the controlled substance, except as provided in (h)1, 2 and 3

below.

A prescription for a Schedule II narcotic substance prescribed for pain management

to be compounded for the direct administration to a patient by parenteral,

intravenous, intramuscular, subcutaneous or intraspinal infusion may be transmitted

by the practitioner or the practitioner's agent to the dispensing pharmacy by

facsimile. The facsimile shall serve as the original written prescription and shall be

maintained pursuant to the requirements of (g) above.

A prescription for a Schedule II substance prescribed for pain management for a

resident of a long-term care facility may be transmitted by the practitioner or the

practitioner's agent to the dispensing pharmacy by facsimile. The facsimile shall

serve as the original written prescription and shall be maintained pursuant to the

requirements of (g) above.

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A prescription for a Schedule II narcotic substance prescribed for pain management

for a patient receiving services from a hospice certified by Medicare under Title XVIII

or licensed by the State may be transmitted by the practitioner or the practitioner's

agent to the dispensing pharmacy by facsimile. The practitioner or the practitioner's

agent shall note on the facsimile prescription that the patient is a hospice patient.

The facsimile shall serve as the original written prescription and shall be maintained

pursuant to the requirements of (g) above.

i) A pharmacist may fill a prescription for a Schedule III, IV or V controlled substance

transmitted by facsimile consistent with the requirements of this section. The facsimile

prescription shall serve as the original written prescription.

j) A pharmacist shall not enter into any agreement with a prescribing practitioner that

requires that facsimile prescriptions be transmitted to a particular pharmacy or in any

way denies a patient the right to have his or her prescription transmitted by facsimile to a

pharmacy of the patient's choice.

k) Nothing in this section shall be construed to preclude the facsimile transfer of information

between pharmacies for purposes of transferring prescriptions pursuant to N.J.A.C.

13:39-7.8.

l) A pharmacist shall not use a technological device in order to circumvent his or her

responsibilities with regard to verifying the validity of prescriptions or in order to

circumvent other standards of pharmacy practice.

13:39-7.11 ELECTRONICALLY TRANSMITTED PRESCRIPTIONS

a) A pharmacist may accept for dispensing an electronic prescription, consistent with the

requirements of this section. For purposes of this section, "electronic prescription" means

a prescription which is transmitted by a computer device in a secure manner, including

computer to computer and computer to facsimile transmissions.

b) A pharmacist shall not fill an electronic prescription transmitted by anyone other than a

practitioner authorized to prescribe medications pursuant to N.J.S.A. 45:14-40, or the

prescribing practitioner's authorized agent. If the electronic prescription is transmitted by

the practitioner's authorized agent, the transmission shall include the full name and title

of the agent.

c) The permitholder shall ensure that the electronic system utilized to receive prescriptions

shall have adequate security and system safeguards designed to prevent and detect

unauthorized access, modification or manipulation of the prescriptions.

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d) The computer or device used to receive electronically transmitted prescriptions shall be

located within the pharmacy prescription area.

e) An electronic prescription shall contain all information required to be included on a

written prescription pursuant to New Jersey State Board of Medical Examiners rule

N.J.A.C. 13:35-7.2(d), except that a handwritten original signature and an NJPB shall not

be required for the prescription. An electronic prescription for a Schedule II controlled

substance shall not be required to include words, in addition to numbers, to indicate the

drug quantity authorized. Consistent with the requirements of N.J.A.C. 13:35-7.4A, the

practitioner's electronic signature or other secure method of validation shall be provided

with the electronic prescription unless the prescription is transmitted by the practitioner's

authorized agent. If transmitted by an authorized agent, the full name and title of the

agent shall be included on the transmission and the agent shall not sign the prescription.

f) A pharmacist shall seek verbal verification of an electronic prescription from the

prescribing practitioner whenever the pharmacist has reason to question the authenticity,

accuracy or appropriateness of the prescription. A pharmacist may accept verbal

verification regarding the authenticity or legibility of an electronic prescription from a

prescribing practitioner's authorized agent. A pharmacist shall not fill the electronic

prescription where there is a question regarding authenticity, accuracy or

appropriateness if such verification is not provided.

g) A pharmacist shall retain a printed copy of an electronic prescription, or a record of an

electronic prescription that is readily retrievable and printable, for a minimum of five

years. The printed copy shall be of non-fading legibility.

h) A pharmacist may fill a prescription for a Schedule II controlled substance transmitted

electronically, provided that the original signed prescription is presented to the

pharmacist prior to the dispensing of the controlled substance. If permitted by Federal

law, and in accordance with Federal requirements, an electronic prescription shall serve

as the original signed prescription.

i) A pharmacist may fill a prescription for a Schedule III, IV or V controlled substance

transmitted electronically, provided that the pharmacist has obtained the original signed

prescription, an oral prescription, or a facsimile prescription from the prescribing

practitioner or the prescribing practitioner's authorized agent prior to the dispensing. If

permitted by Federal law, and in accordance with Federal requirements, an electronic

prescription shall serve as the original signed prescription.

j) A pharmacist shall not enter into any agreement with a prescribing practitioner that

requires that electronic prescriptions be transmitted to a particular pharmacy or in any

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way denies a patient the right to have his or her prescription transmitted electronically to

a pharmacy of the patient's choice.

k) Two or more permit holders may establish a common electronic filing system to maintain

required dispensing information.

l) Nothing in this section shall be construed to preclude the electronic transfer of

information between pharmacies for purposes of transferring prescriptions pursuant to

N.J.A.C. 13:39-7.8.

m) A pharmacist shall not use a technological device in order to circumvent his or her

responsibilities with regard to verifying the validity of prescriptions or in order to

circumvent other standards of pharmacy practice.

13:39-7.12 LABELING

a) The dispensed container for any product shall bear a permanently affixed label with at

least the following information:

The pharmacy name and address;

The pharmacy telephone number;

The brand name, or if a generic, the brand name, if still available in the marketplace,

and the name of the generic in the following form, with the generic name and brand

name inserted as appropriate:

"--------- Generic for ---------"

If the brand name is not still available in the marketplace, the generic name.

The strength of medication, where applicable;

The quantity dispensed;

The date upon which prescription medication is dispensed;

A CDS cautionary label, where applicable;

The patient name;

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The practitioner's name;

10)

The prescription number;

11)

Directions for use;

12)

The phrase "use by" followed by the product's use by date, if dispensed in any

packaging other than the manufacturer's original packaging.

i) For purposes of this paragraph, "use by date" means the earlier of one year from

the date of dispensing or the expiration date on the manufacturer's container; and

13)

For substituted biological products, the information required in N.J.A.C. 13:39-

7.23(d).

b) The patient name, the brand or generic name of the medication, and the directions for

use shall appear in larger type, in a different color type, or in bolded type, in comparison

to the other information required to appear on the label of the dispensed container

pursuant to (a) above.

c) In addition to the requirements set forth in (a) and (b) above, the dispensed container for

any product shall bear all auxiliary labeling as recommended by the manufacturer.

d) When, in the judgment of the pharmacist, directions to the patient or cautionary

messages are necessary, either for clarification or to ensure proper administration,

storage or use of the medication, the pharmacist may add such directions or cautionary

messages to those indicated by the practitioner on the original prescription.

e) In addition to the requirements set forth in this section, when a pharmacist dispenses a

prescription for an opioid medication, the pharmacist shall affix, to the container, a

warning label or sticker such that the label or sticker shall:

Contain the warning, "Opioid Risk of Addiction and Overdose." Punctuation and

layout of the warning may be determined by the permitted pharmacy.

The warning label or sticker must be:

i) Red, orange, or yellow in color;

ii) Written in black color text;

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iii) Printed with a font size of at least 10-point font that is print- or block-based (that

is, not cursive) such that the font and lettering shall be easily and clearly

readable; and

iv) Placed on the side, not the bottom, of the bottle or box that contains the

prescription label, or on the cap of the bottle.

13:39-7.13 PROFESSIONAL JUDGMENT IN DISPENSING DRUGS

The pharmacist shall have the right to refuse to fill a prescription if, in his or her professional

judgment, the prescription is outside the scope of practice of the practitioner; or if the pharmacist

has sufficient reason to question the validity of the prescription; or to protect the health and

welfare of the patient.

13:39-7.14 ADVERTISING AND SALE OF PRESCRIPTION DRUGS

a) "Advertisement" means any attempt directly or indirectly by publication, dissemination, or

circulation in print or electronic media which directly or indirectly induces or attempts to

induce any person or entity to purchase or enter into an agreement to purchase services

or goods from a Board licensee.

b) Price quotations for prescription drugs appearing in any advertisement shall stipulate the

strength and quantity required to be purchased for the offered cost. Price quotations shall

include the usual and customary prescription cost. All services including, but not limited

to, delivery charges rendered by the pharmacy which will add additional costs to the

price quoted, must be set forth in the advertisement.

c) Any reference in any form of advertisement to the quality of a drug or its beneficial use is

prohibited.

d) Price quotations for drugs appearing in any advertisement shall stipulate the effective

period of price quotation.

e) Upon request by any consumer, the pharmacist shall give usual and customary price

information for a non-third party paying customer over the telephone and shall stipulate

the effective period of the price quotation.

f) All advertisements shall be predominantly informational and shall not be misleading,

confusing or false. Any advertisement demeaning the quality of professional services

rendered by another licensee or permittee shall be prohibited.

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13:39-7.15 RESTRICTION ON SALE OF SCHEDULE V OVER-THE-COUNTER

CONTROLLED SUBSTANCES

a) It shall be considered unprofessional conduct for a pharmacist to dispense a Schedule V

over-the-counter controlled substance when:

The pharmacist, in his or her professional judgment, knows or reasonably should

know that the requested substance will be used for unauthorized or illicit consumption

or distribution; or

The pharmacist, in his or her professional judgment, knows or reasonably should

know that the person requesting the substance previously used it for unauthorized or

illicit consumption or distribution.

b) The standard of professional judgment and care that attends the sale of a Schedule V

over-the-counter controlled substance shall conform to the following:

All pharmacists shall comply with N.J.A.C. 13:45H-7.19, which requires that the sale

of specified controlled substances be limited in quantity during any 48-hour period,

that the purchaser be at least 18 years of age, and that the pharmacist obtain

suitable identification (including proof of age where appropriate) from every

purchaser not known to the pharmacist.

In all instances, any doubts regarding the propriety of a sale of a Schedule V

substance shall be resolved against making the sale.

The pharmacist shall enter every sale of a Schedule V substance in the Over-the-

Counter Schedule V Record Book pursuant to N.J.A.C. 13:45H-7.19. The information

to be recorded shall include the purchaser's first and last name, street address, city

and state, the name and quantity of the Schedule V substance sold, the date of each

sale, and the name or initials of the pharmacist making the sale.

Upon an individual's second request for a Schedule V substance within a short period

of time (two to four days), the pharmacist shall determine, through direct

communication with the purchaser, whether the substance is being used correctly. In

that regard, the pharmacist shall ascertain how many people are using the substance

and whether the condition which the substance is being used to treat is improving.

Upon an individual's third request for a Schedule V substance within a short period of

time relative to the number of persons using it (two to four days subsequent to the

second purchase), the pharmacist shall advise the purchaser of the substance's

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abuse potential and shall caution the purchaser to consult a physician if the condition

for which the substance is being used does not improve.

Upon an individual's fourth request for a Schedule V substance within a short period

of time (two to four days subsequent to the third purchase), the pharmacist shall

determine, through direct communication with the purchaser, how many people are

using the substance, whether continued use will be therapeutic, whether the

purchaser is treating a condition which requires a physician's consultation, whether

the purchaser is exhibiting signs of drug abuse and whether the purchaser is making

similar requests of other local pharmacies.

If a pharmacist determines that an individual's request for a Schedule V substance

within a short period of time (two to four days) subsequent to his or her fourth

purchase is warranted, the pharmacist shall document in the Over-the-Counter

Schedule V Record Book the justification for such sale. In addition, the pharmacist

shall recommend that the purchaser consult with a physician for medical evaluation

due to the substance's abuse potential as well as the potential hazard presented by

the substance's continued use.

If any Schedule V substance is dispensed to one individual more than five times

within any 12-month period, the pharmacist shall obtain oral or written confirmation

from the purchaser's physician as to the continued need for the substance and shall

document such confirmation in the Over-the-Counter Schedule V Record Book.

13:39-7.16 RETURN OF PRESCRIPTION MEDICATION

a) Prescription medication correctly dispensed to a patient may be accepted for return by

the pharmacist but shall not be placed in stock for reuse or resale, except as provided in

N.J.A.C. 13:39-9.18(a)2.

b) Prescription medication incorrectly dispensed to a patient shall be accepted for return by

the pharmacist and shall not be placed back in stock for reuse or resale.

c) For purposes of this subsection, a prescription medication shall be considered to be

abandoned when a prescription is prepared and made available for dispensing by the

pharmacy but is not dispensed to the patient for whom it was prepared within two weeks.

Prescription medication that has been prepared for a patient and that is abandoned by a

patient, or that has not been dispensed by a long-term care pharmacy to a patient in a

long-term care facility, may be placed back in stock for reuse or resale provided that:

In the professional judgment of the pharmacist, the prescription medication is eligible

for re-dispensing. Eligible medications are those medications that are able to be

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consumed by a patient within the original time frame established for the medication's

stability and expiration, were maintained under proper storage conditions to ensure

their integrity, and have remained under the exclusive control and custody of the

pharmacy or the patient’s long-term care facility, as applicable, at all times. Products

that have a limited shelf life and/or that have not been stored consistent with

manufacturers' storage requirements may not be re-dispensed;

The prescription medication shall not be placed in manufacturers' stock containers of

different lot numbers and/or with different expiration dates;

Manufacturers' stock containers shall not be overfilled;

In those circumstances in which prescription medications cannot be properly returned

to the original manufacturers' stock containers, the medication shall be held in the

pharmacy in the labeled container in which it has been repackaged. Prior to

redispensing, such medications shall be placed in a new container with a new label

or the original label shall be removed and the container shall be relabeled;

If the manufacturer or the FDA orders a recall of a drug product, the pharmacist shall

assume products held in labeled containers without lot numbers are included in the

recall and proceed accordingly; and

Medications held for re-dispensing shall be used as soon as possible. Such

medications, lacking original lot numbers and expiration dates, shall not be dispensed

to patients later than one year from the date the medications were originally prepared

for dispensing. Re-dispensed medications shall be marked with the same use by date

as the medication which was originally prepared for dispensing.

13:39-7.17 DISPOSAL OF UNWANTED DRUGS

Unwanted drugs shall be disposed of in a manner that does not cause them to become a

health hazard, and in accordance with all local, State, and Federal codes.

13:39-7.18 OUTDATED DRUGS OR DRUGS MARKED "SAMPLE"

No outdated, misbranded, deteriorated, improperly stored or adulterated drugs, or any drugs

marked "sample" or with any like designation or meaning shall be dispensed or placed or

maintained in active stock for use or sale.

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13:39-7.19 PATIENT PROFILE RECORD SYSTEM

a) An electronic patient profile system shall be maintained by all pharmacies for persons for

whom prescriptions are dispensed. The Patient Profile Record System (PPRS) shall be

devised, so as to enable the immediate retrieval of current clinical information necessary

to enable the dispensing pharmacist to identify previously dispensed medication and

patient specific information at the time a prescription is presented for dispensing.

b) The following information shall be recorded in the PPRS:

The family name and the first name of the person for whom the medication is

intended (the patient);

The address and telephone number of the patient;

Indication of the patient's age, birth date or age group (infant, child, adult) and

gender;

The original or refill date the medication is dispensed;

The number or designation identifying the prescription;

The practitioner's name;

The name, strength and quantity of the drug dispensed;

Pharmacist's comments relevant to the patient's drug therapy; and

Any allergies and idiosyncrasies of the patient and any medical conditions that may

relate to drug utilization, as communicated by the patient or the patient's

representative.

i) If there are no patient allergies, idiosyncrasies or medical conditions that may

relate to drug utilization, such information shall be documented in the patient

profile record system.

c) The pharmacist shall use professional judgment to review and monitor the patient profile,

determine if there should be any adjustment in the original patient information and so

indicate the appropriate change in the patient profile record.

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d) All prescription patients who patronize a pharmacy shall have a profile record as

specified by this section, and the pharmacist shall inquire as to whether other

prescription drugs are being concomitantly utilized in order to establish a current drug

history for the patient.

e) A patient profile record shall be maintained or stored in original hard copy form or in any

other media that facilitates the reproduction of the original hard copy and shall be

maintained for a period of not less than five years from the date of the last entry in the

profile record. In using an electronic data processing system, the system shall have the

capability of producing retrievable and readable documents of all original and refilled

prescription data for a period of not less than five years, including the number of refills

authorized by the practitioner. The oldest four years of record information shall be

maintained in such a manner so as to be retrievable and readable within two weeks. The

most recent one year of record information shall be retrievable and readable within one

business day. Records not currently in use need not be stored in the pharmacy, but off-

site facilities used to store such records shall be secure. Patient records shall be kept

confidential, but shall be made available to persons authorized to inspect them under

State and Federal statutes and regulations.

f) If the pharmacy uses an electronic data processing system, an auxiliary recordkeeping

system shall be established when the electronic data processing system is inoperative

for any reason. When the electronic data processing system is restored to operation, the

patient profile information and number of refills authorized during the time the electronic

system was inoperative shall be entered into the electronic data processing system

within 72 hours.

g) If an electronic data processing system is used, the system shall provide adequate

safeguards against manipulation and alteration of records and to protect confidentiality of

the information contained in the data bank.

h) The holder of the pharmacy permit shall make arrangements with the supplier of data

processing services or materials to ensure that the pharmacy will continue to have

adequate and complete prescription and dispensing records if the relationship with such

supplier terminates for any reason.

13:39-7.20 DRUG UTILIZATION REVIEW

a) Upon receipt of a new or refill prescription, a pharmacist shall examine the patient's

profile record before dispensing the medication, to determine the possibility of a

potentially significant drug interaction, reaction or misutilization of the prescription. Upon

determining a potentially significant drug interaction, reaction or misutilization, the

pharmacist shall take the appropriate action to avoid or minimize the problem, which

shall, if necessary, include consultation with the patient and/or the practitioner.

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b) Upon receipt of a refill prescription, a pharmacist shall determine if a substantial time, as

is appropriate for that drug in the pharmacist's professional judgment, has elapsed from

the last filling. When necessary, the pharmacist shall consult with the practitioner and/or

the patient to ensure that continued use of the medication is appropriate.

c) When patient profile records indicate sporadic, erratic or irrational use of medication by a

patient, the pharmacist shall consult with the patient and/or the practitioner to determine

if continued use of the medication is appropriate.

13:39-7.21 PATIENT COUNSELING

a) Except as provided in (a)5 below, before dispensing a new medication, a pharmacist

shall make reasonable efforts to counsel the patient or the patient's caregiver.

Counseling may include the following:

The name and description of the medication;

The dosage form, dosage, route of administration, and duration of drug therapy;

Special directions and precautions for preparation, administration and use by the

patient;

Common adverse or severe side effects or interactions and contraindications that

may be encountered, including how to avoid such side effects, interactions and

contraindications, and the action required if they occur;

Techniques for self-monitoring drug therapy;

Proper storage;

Prescription refill information; and

Action to be taken in the event of a missed dose.

b) The offer to counsel may be made by pharmacy personnel. However, counseling shall be

performed only by a pharmacist, or by a pharmacy intern or pharmacy extern under the

immediate personal supervision of a pharmacist consistent with the requirements of

N.J.A.C. 13:39-6.2(f)5.

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c) A pharmacist shall not be required to counsel a patient or caregiver when the patient or

caregiver refuses such counseling.

d) If the patient or caregiver is not physically present, the offer to counsel shall be made by

telephone or in writing on a separate document accompanying the prescription. A written

offer to counsel shall be in bold print, easily read, and shall include the hours a

pharmacist is available and a telephone number where a pharmacist may be reached.

The telephone service must be available at no cost to the pharmacy's primary patient

population.

e) At the time of dispensing, the pharmacist shall document that counseling was provided or

refused.

f) The requirements of this section shall not apply to a pharmacist who dispenses any drug

to an inpatient at a hospital or a long term care facility in which the resident is provided

with 24-hour nursing care.

13:39-7.22 ACCURATE PROCESSING AND DISPENSING

A pharmacist shall be responsible for the processing, accuracy, appropriateness, and

dispensing of the filled prescription.

13:39-7.23 BIOLOGICAL PRODUCTS

a) A pharmacist may substitute a biological product for a prescribed biological product,

provided that the following conditions are met:

The authorized prescriber has not indicated that there shall be no substitution as set

forth in N.J.S.A. 24:6E-7; and

The biological product to be substituted has been determined by the Federal Food

and Drug Administration (FDA) to be:

i) Interchangeable with the prescribed biological product; or

ii) Therapeutically equivalent to the prescribed biological product.

b) If a pharmacist dispenses a biological product, the pharmacist or the pharmacist’s

designee shall, within five business days following the dispensing of the biological

product, communicate to the prescriber the specific product provided to the patient,

including the name of the product and the manufacturer. No communication shall be

required under this subsection when:

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There is no biological product that has been determined by the FDA to be either:

i) Interchangeable with the product prescribed; or

ii) Therapeutically equivalent to the product prescribed; or

A refill prescription is not changed from the product dispensed on the prior filling of

the prescription.

c) The communication requirement under (b) above may be satisfied by making an entry in

an interoperable electronic medical records system or an electronic pharmacy record that

can be accessed electronically by the prescriber, or through the use of another electronic

prescribing technology that can be accessed electronically by the prescriber. Entry into

an electronic records system as described in this subsection is presumed to provide

notice to the prescriber. Otherwise, the communication may be conveyed using other

electronic means, if available, or by facsimile.

d) A pharmacist who substitutes a biological product in compliance with this section shall

record, on the prescription label and record of dispensing, the product name and

manufacturer of the biological product dispensed, followed by the words: “Substituted for”

and the name of the biological product for which the prescription was written.

e) The recordkeeping requirements of this subchapter and N.J.A.C. 13:39-9, as applicable,

which apply to the dispensing of drugs shall apply to the dispensing of biological

products.

f) The Board shall maintain a link to the current list of all biological products determined by

the FDA to be interchangeable pursuant to section 351 of the Public Health Service Act

(42 U.S.C. § 262) on the Board’s website.

SUBCHAPTER 8.

(RESERVED)

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SUBCHAPTER 9.

PHARMACEUTICAL SERVICES FOR HEALTH CARE FACILITIES

13:39-9.1 PURPOSE AND SCOPE

a) The rules in this subchapter shall apply to all retail pharmacies which contract to provide

pharmaceutical services for healthcare facilities and to all institutional pharmacies which

provide pharmaceutical services for their own health care system.

b) An institutional pharmacy filling prescriptions for outpatient use shall comply with all retail

pharmacy requirements of this chapter.

13:39-9.2 DEFINITIONS

The following words and terms, as used in this subchapter, shall have the following

meanings, unless the context clearly indicates otherwise.

"Drug administration" means a procedure in which a prescribed drug is given to a patient by

an authorized person in accordance with all laws and rules governing such procedures.

"Formulary" means a continually revised compilation of pharmaceuticals available in the

pharmacy for use in the facility developed by the Pharmacy and Therapeutics Committee.

"Health care facility" means a facility or institution licensed by the Department of Health

pursuant to N.J.S.A. 26:2H-1 et seq.

"Health care system" means one or more health care facilities which are owned or controlled

by the same legal entity.

"Institutional pharmacy" means the area in a health care facility or a health care system

licensed by the Board as a pharmacy that maintains an institutional permit. "Institutional

pharmacy" includes any areas of the health care facility or the health care system where

pharmaceuticals are stored, compounded or dispensed.

"Medication order" means a written request for medication originated by a practitioner and

intended for patient use in the health care facility, and not for use of the institution's employees

or their dependents or outpatients of the facility's clinics. A valid medication order contains the

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date ordered, the patient's name and location within the facility, the name, dose, route, and

frequency of administration of the medication, and any additional instructions. Computer-

generated medication orders within an institutional setting, utilizing the practitioner's electronic

signature or password will meet legal requirements for a practitioner's original handwritten

signature on medication orders. Computerized signatures or passwords will be accepted

provided that the facility has adequate safeguards which assure the confidentiality of each

electronic signature or password and which prohibit their improper or unauthorized use.

"Pharmacy and Therapeutics Committee" means the active standing committee of the

institution or health care facility which is the organizational line of communication and liaison

between the medical service and pharmacists and which acts to review and promote rational

drug therapy and utilization in the facility.

"Unit dose packaging" means a single unit use non-parenteral medication provided in

packaging which contains the following information for each unit in the package:

Product name;

Strength and/or quantity and/or volume, where appropriate;

Lot number;

The phrase "use by" followed by the product's use by date.

i) For purposes of this paragraph, "use by date" means the earlier of one year from the

date of packaging or the expiration date on the manufacturer's container;

c) Manufacturer or repackager; and

d) If there is more than one product in the single unit, a physical description of each

medication in the single unit.

13:39-9.3 LICENSURE OF INSTITUTIONAL PHARMACIES

a) Any institutional pharmacy as defined under N.J.A.C. 13:39-9.2 shall be registered with

and possess an institutional permit issued by the Board. The permit shall be

conspicuously displayed in the facility's pharmacy. The institutional pharmacy is subject

to and shall be conducted in accordance with all existing State and Federal rules and

regulations.

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b) An institutional pharmacy that is part of a health care system may fill medication orders

for health care facilities that are part of the health care system and that provide

pharmaceutical services directly to the patients of the health care system.

13:39-9.4 CONTRACT PHARMACEUTICAL SERVICES; INSTITUTIONAL PERMIT

REQUIRED

An institutional permit is required for any area within an institution serviced by an outside

vendor that performs on-site pharmaceutical services as defined in N.J.A.C. 13:39-1.2.

13:39-9.5 ADVISORY COMMITTEES

The pharmacist-in-charge, or designee, shall be an actively participating member on any

committees of the facility that may be concerned with drugs and their utilization.

13:39-9.6 PHARMACY AND THERAPEUTICS COMMITTEE; APPLICABILITY;

POLICIES AND PROCEDURES

a) In all health care facilities providing pharmaceutical services to patients, an active

standing committee of the institution entitled the Pharmacy and Therapeutics Committee

or other appropriate name shall be established if required pursuant to Department of

Health rules. A Pharmacy and Therapeutics Committee shall be multidisciplinary and

include a pharmacist.

b) In all health care facilities providing pharmaceutical services to patients that are not

required to maintain a Pharmacy and Therapeutics Committee pursuant to Department of

Health rules, the pharmacist-in-charge of the provider pharmacy, in cooperation with the

health care facility, shall create policies and procedures as needed to provide

pharmaceutical services to the health care facility. Copies of the policies and procedures

shall be made available to the Board upon request.

13:39-9.7 (RESERVED)

13:39-9.8 CONTROL OF HEALTH CARE PHARMACEUTICAL SERVICES;

RESPONSIBILITIES OF THE PHARMACIST-IN-CHARGE OF THE PROVIDER

PHARMACY

a) The pharmaceutical services of the health care facility shall be the responsibility of and

under the control, supervision, and direction of the pharmacist-in-charge of the provider

pharmacy.

b) If a health care facility does not have an institutional pharmacy on its premises or

chooses to utilize the services of a pharmacy outside the health care system, it may

enter into an agreement with a retail pharmacy licensed by the Board. The pharmacist-in-

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charge of the retail pharmacy shall direct, control, supervise and be responsible for the

pharmaceutical services provided to the facility.

c) The pharmacist-in-charge of the provider pharmacy, with the cooperation of the

Pharmacy and Therapeutics Committee, shall develop written policies and procedures as

needed to provide pharmaceutical services to the facility. The written policies and

procedures shall be available to the Board.

13:39-9.9 (RESERVED)

13:39-9.10 PHARMACEUTICALS; DRUG SUPPLY; INVESTIGATIONAL DRUGS;

CONTROLLED DANGEROUS SUBSTANCES

a) The pharmacist-in-charge shall be responsible for determining the specifications for

drugs and pharmaceutical preparations used in the treatment of patients of the facility as

to quality, quantity and source of supply. An authorized purchasing agent and/or

materials manager and/or pharmacy buyer of the facility may perform the actual

procurement. All purchases shall be reviewed by the pharmacist-in-charge or his or her

designee, who shall be a pharmacist.

b) Written policies and procedures for the maintenance, content, control and accountability

of drugs supplied and located throughout the facility shall be developed by the

pharmacist-in-charge and approved by the Pharmacy and Therapeutics Committee.

c) Written policies and procedures for the control, use, and accountability of Investigational

New Drugs shall be developed by the pharmacist-in-charge and the Pharmacy and

Therapeutics Committee. The storage, labeling and dispensing of all Investigational New

Drugs shall be a pharmaceutical service provided in cooperation with, and in support of

the principal investigator. Under these parameters, the dispensing of these drugs shall

not be construed to be a violation of N.J.A.C. 13:39-7.5(a). A facility participating in

experimental research involving residents shall comply with Federal Department of

Health and Human Services regulations, set forth at 45 CFR Part 46, Protection of

Human Subjects of Research, which is incorporated by reference herein, as amended

and supplemented and with the Rowan University Guidance on Human Subjects

Research, which is incorporated herein by reference, as amended and supplemented,

and which is available at http://www.rowan.edu/som/hsp/guidance/index.html

d) Written policies and procedures for the control, use and accountability of controlled

dangerous substances shall be developed by the pharmacist-in-charge and the

Pharmacy and Therapeutics Committee. Controlled dangerous substances shall be

purchased, received, stored, dispensed, administered, recorded and controlled in

accordance with State and Federal laws and regulations.

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13:39-9.11 DRUG DISBURSEMENT; WRITTEN ORDERS

a) The pharmacist shall review the practitioner's original order or a copy of the original

order generated by any media that facilitates the reproduction of the original order before

any initial dose of medication is dispensed, except as provided for in N.J.A.C. 13:39-

9.13.

b) Drugs not specifically limited as to time or number of doses when ordered shall be

controlled by the automatic stop order procedure or other methods in accordance with

written policies of the facility.

c) The Pharmacy and Therapeutics Committee shall develop a list of unapproved or

unacceptable abbreviations and symbols which shall not be used in the facility. Orders

involving symbols or abbreviations shall only be dispensed consistent with this list.

d) When appropriate, the pharmacist shall make necessary entries into the patient medical

record relative to drug use in accordance with health care facility policies and, where

applicable, pursuant to regulations of the Department of Health and/or Centers for

Medicare and Medicaid Services.

13:39-9.12 DRUG DISBURSEMENT; ORAL ORDERS

a) The provisions of this section shall be implemented in accordance with the policies and

procedures of, and protocols of the Pharmacy and Therapeutics Committee.

b) A pharmacist shall receive oral orders only from an authorized practitioner. Such orders

shall be immediately recorded and signed by the person receiving the order on the

medication order sheet or into the electronic data processing system.

c) Oral orders for Schedule II controlled substances shall be permitted only in the case of a

bona fide emergency situation.

d) Oral orders received consistent with the requirements of (b) and (c) above shall be

countersigned by the practitioner.

e) The pharmacist may release to the patient at discharge any remaining medication in a

multiple dose container (for example, inhalers, multiple dose injectable medications, such

as insulin, topical preparation, drops, ointments and topical irrigation solutions), and a

limited supply of other medications, provided that the pharmacist:

Labels the medications for out-patient use pursuant to labeling requirements set forth

in N.J.A.C. 13:39-7.12;

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Counsels the patient prior to discharge from the hospital or medical facility pursuant

to N.J.A.C. 13:39-7.21; and

Ensures that discharge orders contain the attending physician's authorizations to

dispense the remaining doses of the prescription or the limited supply of other

medications to the patient or guardian.

13:39-9.13 MONITORING OF PATIENT DRUG THERAPY

a) The pharmacist shall be responsible for monitoring drug therapy of patients in the facility.

This shall include, but is not limited to, maintaining and reviewing the patient medication

profile prior to the dispensing of medications.

b) In instances involving the issuance and administration of STAT orders (orders requiring

immediate attention) these drugs shall be documented on the patient's medication profile

immediately after dispensing.

c) When the pharmacy is closed, these drugs shall be documented on the patient's

medication profile immediately after the pharmacy is reopened.

13:39-9.14 MEDICATION NOT DISPENSED IN FINISHED FORM

The pharmacist shall be responsible for providing medication in a form that requires little or

no further alterations, preparation, reconstitution, dilution or labeling by other licensed

personnel. The pharmacist shall provide adequate instructions for those products that are not

dispensed in finished form.

13:39-9.15 DRUG LABELING

Labeling of medications, other than intravenous solutions, shall be in conformance with

written policies and procedures controlling the drug distribution system in use within the facility

and in accord with current acceptable standards of pharmaceutical practice. Labeling of

intravenous solutions shall be consistent with the labeling requirements set forth in N.J.A.C.

13:39-11.

13:39-9.16 USE OF PATIENT'S OWN MEDICATION

a) No drugs shall be administered to a patient except those provided through the pharmacy

or as provided by written policies and procedures developed by the pharmacist-in-charge

or, where applicable, the director of pharmaceutical services and approved by the

Pharmacy and Therapeutics Committee.

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b) Although the use of patient's own medications may be warranted in certain situations, it

should be discouraged as a general or routine practice. If a patient's previously acquired

medication is to be used, a written order to this effect shall be signed and dated by the

patient's physician. Such medications shall be identified by the pharmacist as to contents

and dispensing origin. Also, these medications shall be documented as part of the

pharmacy's patient profile record system.

13:39-9.17 DRUG-DISPENSING DEVICES

a) Where the use of a drug-dispensing device is approved as an integral part of the drug

distribution system by the facility, the pharmacist-in-charge and the Pharmacy and

Therapeutics Committee, the device may be used when the pharmacist is not on duty

(absent during either the day or night), provided that any absence of the pharmacist does

not exceed 24 hours, or when the pharmacist is on duty, provided that proper review of

the use of the drug-dispensing device can be ascertained. The supervision of any drug

dispensing device so utilized shall be the responsibility of the pharmacist-in-charge

servicing the health care facility. The drug-dispensing device data shall be checked for

accuracy every 24 hours by a pharmacist and so documented.

b) Packaging and labeling of medication for drug-dispensing devices, when done by the

pharmacy, shall be performed under the immediate personal supervision of a pharmacist

in the employ of or under contract to the facility.

c) Stocking of the drug-dispensing devices with prepackaged medications shall be

performed by or under the supervision of a pharmacist.

d) The cleanliness of the drug dispensing devices shall be maintained by a pharmacist or by

a person under the supervision of a pharmacist.

e) Controlled substances and other medications to which, in the professional judgment of

the pharmacist-in-charge, access should be limited, shall be secured within the drug

dispensing device to limit access to single medications only and shall be checked and

documented by the pharmacist or his or her designee who shall be a licensed health care

professional, every 24 hours. Other than a pharmacist, only authorized registered

nurses, licensed practical nurses, practitioners, pharmacy technicians, interns and

externs shall have access to the medication in each drug-dispensing device. The activity

regarding all medication, including the identity of the person accessing the medication,

shall be recorded and available to the pharmacist.

f) All medications withdrawn from a drug dispensing device require a medication order by

an authorized practitioner. All such medication orders shall be checked by the

pharmacist within 24 hours from the time of the original order and so noted on the

pharmacy's patient medication profile.

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g) When there is no pharmacy on the premises and when the drug-dispensing devices are

an integral part of the approved drug distribution system of the facility, the devices shall

be controlled by the pharmacist-in-charge who is responsible for the pharmaceutical

services of the institution. Under these circumstances, the time between medication

order checks shall not exceed 24 hours.

13:39-9.18 DISPOSAL OF UNUSED MEDICATIONS

a) Written policies and procedures governing unused medications shall be established and

implemented by the pharmacist-in-charge and shall comply with the following

requirements:

All medications where the drug source, lot or control number, or expiration or use by

date are missing, shall be sent to the pharmacy for final disposition, or shall be

disposed of by the health care facility according to its written protocol.

If a unit dose packaged medication has been stored in a medication room or secure

area in the institution and the medication seal and control number are intact, the

medication may be recycled and redispensed.

Any and all medication returned by out-patients of the facility shall not be

redispensed.

The record of disposal of unused or nonadministered dispensed controlled dangerous

substances expended or wasted either by accident or intent shall be signed and co-

signed and witnessed by a licensed nurse, physician, or pharmacist, or where

allowed by Department of Health rules an administrator of the health care facility, and

disposed of by the health care facility according to its written protocol and consistent

with all local, State, and Federal laws and regulations.

13:39-9.19 RECORDS AND REPORTS

a) Records of the pharmaceutical services of the provider pharmacy for the facility shall be

the responsibility of the pharmacist-in-charge. A pharmacy shall maintain an audit trail

that records and documents the unique and secure user identifier(s) of the pharmacist(s),

pharmacy technician(s), intern(s), or extern(s) performing the component functions of

intake, processing, fulfillment, and dispensing of prescriptions as defined in N.J.A.C.

13:39-4.19, which are required to be performed by a pharmacist, pharmacy technician,

intern, or extern pursuant to the requirements of this chapter. The collection of

demographic information for the patient profile as provided for in N.J.A.C. 13:39-6.15(a)2i

is not required to be, but may be, recorded in the audit trail. All entries to the audit trail

made by a pharmacy technician, intern, or extern shall be reviewed and approved by the

pharmacist. The pharmacist shall be responsible for the accuracy and appropriateness of

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the filled prescription. When more than one pharmacist is involved in the component

functions of prescription handling, each pharmacist shall be responsible for the accuracy

and appropriateness of each component function he or she performed or reviewed and

approved, and his or her unique and secure user identifier(s) shall be recorded in an

audit trail. Audit trail documentation shall be generated at the time the component

function(s) is performed. All audit trail and medication order information shall be

maintained or stored in original hard copy form or in any other media that facilitates the

reproduction of the original hard copy and shall be maintained for a period of not less

than five years. The oldest four years of information shall be maintained in such a

manner so as to be retrievable and readable within two weeks. The most recent one year

of information shall be retrievable and readable within one business day. Records not

currently in use need not be stored in the pharmacy, but off-site facilities used to store

such records shall be secure. Patient records shall be kept confidential, but shall be

made available to persons authorized to inspect them under State and Federal statutes

and regulations.

b) The pharmacy shall maintain a patient profile record for each patient receiving drug

therapy in accordance with N.J.A.C. 13:39-7.19 and as follows:

The profile records for inpatients shall contain: the date of each entry; the name; sex;

age or birthdate; location of the patient; the drug name, dose, route of administration

and quantity dispensed; the reported diagnosis, allergies and chronic condition(s) of

the patient.

All notations made on the inpatients' profile records by pharmacy technicians, interns

and externs shall be verified and countersigned, either manually or electronically, by

the supervising pharmacist.

The inpatient profile record shall be filed and stored for five years following patient

discharge. The oldest four years of information shall be maintained in such a manner

so as to be retrievable and readable within two weeks. The most recent one year of

information shall be retrievable and readable within one business day.

c) All outpatient prescriptions dispensed and outpatient profile records in the institutional

pharmacy shall conform to the requirements set forth in N.J.A.C. 13:39-7.6.

d) Records for receipt, use and final disposition of controlled dangerous substances shall

be maintained by the institutional pharmacy in compliance with the requirements of

Federal and State controlled dangerous substances laws and regulations. Nursing

administration and audit records for controlled dangerous substances shall be available

for review by the pharmacy.

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e) Records of the receipt, dispensing and disposal of investigational drugs shall be

maintained by the institutional pharmacy in compliance with Federal and State laws and

regulations.

f) The pharmacist-in-charge shall be responsible for maintaining a system by which all

reported adverse drug reactions are recorded and reviewed by the Pharmacy and

Therapeutics Committee, where applicable, and are submitted to all appropriate State

and local agencies consistent with State and local laws and regulations.

13:39-9.20 DRUG INFORMATION AND EDUCATION

a) The pharmacist-in-charge shall be responsible for maintaining drug standards,

references and sources of drug information current and adequate to meet the needs of

the pharmacists, physicians, nurses, other health care personnel, and patients of the

facility. Reference texts shall include, but not be limited to, those required by the Board

under N.J.A.C. 13:39-5.8.

b) On each patient care unit, the pharmacist shall maintain the following:

A copy of the current institutional formulary;

A reference drug compendium which will give basic information concerning drugs

approved by the Pharmacy and Therapeutics Committee; and

The telephone number of either the local or regional poison control center.

c) The pharmacist shall participate in the drug education programs of the facility.

13:39-9.21 AFTER HOURS ACCESS TO THE INSTITUTIONAL PHARMACY

a) Only a pharmacist shall have access to the pharmacy stock of controlled dangerous

substances in Schedules II through V.

b) Only a pharmacist shall have access to the institutional pharmacy except that in a

pharmacist's absence from an institution, a registered nurse designated by the registered

pharmacist-in-charge may obtain medication from the hospital pharmacy as needed in an

emergency and not available as floor stock.

c) A designated registered nurse shall remove only those medication doses which shall be

administered prior to the opening of the pharmacy. The designated registered nurse may

remove the following from the pharmacy stock of drugs or automated dispensing device:

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A drug in its original container or a drug prepackaged by the pharmacy for use in the

institution;

The required dose(s) of a drug from the original container for a specific patient.

d) The pharmacist-in-charge shall obtain from the registered nurse on a suitable form a

record of any drugs removed showing the following:

The name of the drug;

The dosage size;

The amount taken;

The date;

The patient's name and location; and

The signature of the nurse.

e) The pharmacist-in-charge shall obtain with the record in (d) above the container from

which the required dose(s) was taken for drug administration purposes in order that it

may be properly checked by a pharmacist.

f) All records in (d) above shall be maintained or stored in original hard copy form or in any

other media that facilitates the reproduction of the original hard copy, and shall be kept

by the pharmacy for five years. The oldest four years of information shall be maintained

in such a manner so as to be retrievable and readable within two weeks. The most recent

one year of information shall be retrievable and readable within one business day.

Records not currently in use need not be stored in the pharmacy, but off-site facilities

used to store such records shall be secure. Patient records shall be kept confidential, but

shall be made available to persons authorized to inspect them under State and Federal

statutes and regulations.

13:39-9.22 PHARMACY FACILITIES; SPACE

a) Adequate facilities (space, lighting, equipment, temperature control and supplies) shall

be provided for the control of the professional, technical and administrative functions of

the institutional pharmacy as needed for the effective and efficient assurance of patient

safety through proper purchasing, receipt, storage, dispensing, administration and

control of drugs.

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b) The facilities shall include, but are not limited to, those requirements provided in N.J.A.C.

13:39-5.4 through 5.8 and 5.11.

13:39-9.23 STORAGE AND SECURITY

a) Provisions shall be made for adequate safe storage of drugs wherever they are stored in

the health care facility.

All drugs shall be secured for safe use and protected against illicit diversion.

Controlled dangerous substances in the institutional pharmacy and throughout the

facility shall be stored and protected in conformance with State and Federal laws and

regulations.

Supplies of external preparations stored in patient care areas shall be kept separate

from internal medications.

The pharmacist-in-charge or, where provided for in Department of Health rules, the

director of pharmaceutical services shall be responsible for all the medications in the

facility.

The drugs throughout the facility shall be maintained under adequate storage

conditions including proper lighting, ventilation and temperature control as required

by N.J.A.C. 13:39-5.7(b).

b) The pharmacist-in-charge or, where provided for in Department of Health rules, the

director of pharmaceutical services shall establish a system of control for all drugs

dispensed for use in the drug therapy of patients of the facility. Inspections shall be

conducted of all medication areas located in the facility or any other service area of the

facility at least once every two months to check for expiration or use by dates, proper

storage, misbranding, physical integrity, security and accountability of all drugs. These

inspections shall be fully documented. Written inspection reports shall be prepared and

signed by the inspecting pharmacist or by the pharmacy technician, intern or extern and

co-signed by his or her supervising pharmacist. The pharmacist-in-charge shall be

responsible for ensuring that, prior to performing any inspections pursuant to this

subsection, pharmacy technicians, interns and externs are trained and can successfully

demonstrate competency. Procedures for the review of these reports shall be developed

and instituted by the pharmacist-in-charge and can be incorporated into the overall

quality assurance program of the health care facility.

c) Procedures shall be established to assure the immediate and efficient removal of all

outdated and recalled drugs from patient care areas and from the active stock of the

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pharmacy. The pharmacist-in-charge shall develop written policies and procedures

governing the removal from the facility of outdated or recalled drugs.

13:39-9.24 EQUIPMENT

Adequate equipment shall be provided for the compounding, packaging, labeling,

refrigeration, sterilization, testing and safe distribution of drugs and other functions.

13:39-9.25 INSTITUTIONAL DECENTRALIZED PHARMACIES

a) An institutional decentralized pharmacy or a "satellite pharmacy", means an area within a

health care system that has been issued an institutional permit and is in a location other

than the original permitted location, where the preparation or dispensing or compounding

of medications is performed.

b) Medication shall not be dispensed from a decentralized pharmacy without a pharmacist

present, except that, when the decentralized pharmacy is closed, a licensed nurse may

dispense medication in accordance with the written policies and procedures of the

institution.

c) Institutions operating decentralized pharmacies shall notify the Board, in writing, of the

existence of, and the discontinuation of, each decentralized pharmacy location.

d) Institutional decentralized pharmacies shall be subject to normal Board inspections.

e) Inspections of all medications in a decentralized institutional pharmacy shall be

performed consistent with the requirements of N.J.A.C. 13:39-9.23.

f) Institutional decentralized pharmacies shall comply with all requirements in this

subchapter applicable to the pharmaceutical services provided by the decentralized

pharmacy, as determined by the pharmacist-in-charge.

13:39-9.26 VALID MEDICATION ORDERS; OUT-OF-STATE MEDICATION ORDERS

a) Only medication orders issued by a practitioner licensed to write medication orders in the

United States or any territory of the United States shall be considered valid medication

orders and such medication orders shall be filled pursuant to New Jersey law.

b) Medication orders, other than those listed in (a) above, shall not be filled by a pharmacy

in New Jersey.

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13:39-9.27 PRESCRIPTIONS AND MEDICATION ORDERS TRANSMITTED BY

TECHNOLOGICAL DEVICES IN AN INSTITUTION

a) A pharmacist may, subject to the conditions set forth in this section, accept for

dispensing a prescription or a medication order transmitted by a facsimile (FAX) machine

or other technological device as approved by the Board.

b) A pharmacist filling prescriptions under an institutional permit for employees of the

institution and their dependents and for eligible outpatients may accept for dispensing

prescriptions for all substances consistent with the requirements of N.J.A.C. 13:39-7.10

and 7.11.

c) A pharmacist who is authorized to fill inpatient medication orders, as defined in N.J.A.C.

13:39-9.2, in an institutional pharmacy may accept all inpatient medication orders,

including orders for Schedule II substances, which have been transmitted by

technological device.

d) Whenever a pharmacist has reason to question the accuracy or authenticity of a

prescription or medication order transmitted by technological device, the pharmacist shall

verify the transmission directly with the prescribing practitioner.

e) It shall be deemed professional misconduct for a pharmacist to use a technological

device in order to circumvent his or her responsibilities with regard to documenting,

authenticating and verifying medication orders and prescriptions or in order to circumvent

other standards of pharmacy practice.

f) No licensee or permit holder registered under N.J.S.A. 45:14-40 et seq. shall under any

circumstances provide a technological device to, or accept a technological device from,

any practitioner licensed to write prescriptions.

g) No licensee or permit holder shall enter into any agreement with an authorized

practitioner which denies the patient the right to have his or her prescription transmitted

by technological device to a pharmacy of the patient's choice.

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SUBCHAPTER 10.

AUTOMATED MEDICATION SYSTEMS

13:39-10.1 PURPOSE AND SCOPE

The rules in this subchapter establish standards applicable to all pharmacies and/or facilities

that utilize automated medication systems to store, package, dispense and distribute

prescriptions or medication orders.

13:39-10.2 "AUTOMATED MEDICATION SYSTEM" DEFINITION

As used in this subchapter, "automated medication system" means any process that

performs operations or activities, other than compounding or administration, relative to the

storage, packaging, dispensing and distribution of medications, and which collects, controls and

maintains all transaction information. "Automated medication system" does not mean an

automatic counting device operated pursuant to N.J.A.C. 13:39-5.9 or a drug dispensing device

operated pursuant to N.J.A.C. 13:39-9.17.

13:39-10.3 AUTHORITY TO USE AUTOMATED MEDICATION SYSTEM

a) Prior to use for the first time of an automated medication system, the pharmacy shall

conduct and submit to the Board a self-inspection of the automated medication system

documented on a form provided by the Board. After receipt of the self-inspection, the

Board shall conduct an inspection of the automated medication system. The pharmacy

shall not use the system until it receives Board approval.

b) A pharmacy may use an automated medication system to fill prescriptions or medication

orders provided that the pharmacy:

Conducts an annual self-inspection of the automated medication system documented

on a form provided by the Board. The pharmacy shall make the self-inspection

available to the Board upon request;

Tests the automated medication system consistent with N.J.A.C. 13:39-10.6. The

pharmacy shall make the results of such testing available to the Board upon request;

and

Makes the automated medication system available to the Board for the purpose of

inspection, whereby the Board may validate the accuracy of the self-inspection

and/or of the system.

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c) The pharmacist-in-charge shall be responsible for the following:

Supervision of the operation of the system, or in the case of an automated

medication system utilized at a location with no on-site pharmacy, the pharmacist-in-

charge of the provider pharmacy shall be responsible for the supervision of the

operation of the system;

Ensuring that there are written policies and procedures, which are reviewed and

approved by the pharmacist-in-charge for system operation, safety, security,

accuracy, and access, patient confidentiality and prevention of unauthorized access

and malfunction, and ensuring compliance with such policies and procedures;

Ensuring that the pharmacy conducts an annual self-inspection of the automated

medication system documented on a form provided by the Board. Such inspection

shall verify that the automated medication system has been tested by the pharmacy

and found to dispense accurately;

Ensuring that medications in the automated medication system are inspected, at

least once every two months, for expiration or use by date, misbranding and physical

integrity, and ensuring that the automated medication system is inspected, at least

once every two months, for security and accountability;

Assigning, discontinuing or changing personnel access to the automated medication

system;

Ensuring that the automated medication system is stocked accurately and an

accountability record is maintained in accordance with the written policies and

procedures of operation; and

Ensuring compliance with all applicable provisions of N.J.A.C. 13:39.

13:39-10.4 WRITTEN POLICIES AND PROCEDURES OF OPERATION

a) When an automated medication system is used to fill prescriptions or medication orders,

it shall be operated according to written policies and procedures of operation. The

policies and procedures of operation shall:

Include a table of contents;

Include a description of all procedures of operation;

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Set forth methods that shall ensure retention of each amendment, addition, deletion

or other change to the policies and procedures of operation for at least two years

after the change is made. Each such change shall be signed or initialed by the

pharmacist-in-charge and shall include the date on which the pharmacist-in-charge

approved the change;

Set forth methods that shall ensure that a pharmacist currently licensed in the

transmitting jurisdiction reviews and approves the transmission of each original or

new prescription or medication order to the automated medication system before the

transmission is made;

Set forth methods to identity the quality control measures in place to ensure the

accuracy of the final dispensed product;

Set forth methods that shall ensure that access to the records of medications and

other medical information of the patients maintained by the pharmacy is limited to

licensed practitioners or personnel approved to have access to the records, for the

purpose of complying with N.J.A.C. 13:39-7.19;

Set forth methods that shall ensure that access to the automated medication system

for stocking and retrieval of medications is limited to licensed practitioners or

qualified pharmacy technicians, interns and externs under the supervision of a

pharmacist. An accountability record, which documents all transactions relative to

stocking and removing medications from the automated medication system shall be

maintained; and

Identify the circumstances under which medications may be removed from the

automated medication system by a licensed practitioner for distribution to a patient

without prior order review by a pharmacist.

b) A pharmacy which uses an automated medication system to fill prescriptions or

medication orders shall, at least annually, review its written policies and procedures of

operation and revise them if necessary.

c) A copy of the written policies and procedures of operation adopted pursuant to this

section shall be retained at the pharmacy and at the healthcare facility where the

automated medication system is utilized. Upon request, the pharmacy shall provide to

the Board a copy of the written policies and procedures of operation for inspection and

review.

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13:39-10.5 PERSONNEL TRAINING REQUIREMENTS

The pharmacist-in-charge shall be responsible for ensuring that, prior to performing any

services in connection with an automated medication system, all pharmacists and pharmacy

technicians, interns and externs are trained in the pharmacy's standard operating procedures

with regard to automated medication systems as set forth in the written policies and procedures

of operation maintained pursuant to N.J.A.C. 13:39-10.4.

13:39-10.6 WRITTEN PROGRAM FOR QUALITY ASSURANCE

a) A pharmacy which uses an automated medication system to fill prescriptions or

medication orders shall operate according to a written program for quality assurance of

the automated medication system which:

Requires continuous monitoring of the automated medication system;

Establishes mechanisms and procedures to test the accuracy of the automated

medication system at least every six months and whenever any upgrade or change is

made to the system;

Establishes a protocol for measuring the effectiveness of the automated medication

system;

Requires the pharmacy to report to the Board each recurring error of the automated

medication system. A "recurring error," for purposes of this section, means any

specific type of inaccuracy within the automated medication system that occurs more

than twice within a 14 day period; and

Requires the pharmacy to maintain all documentation relating to the written program

for quality assurance for at least two years.

13:39-10.7 WRITTEN PLAN FOR RECOVERY

a) A pharmacy which uses an automated medication system to fill prescriptions or

medication orders shall maintain a written plan for recovery from a disaster which

interrupts the ability of the pharmacy to provide services. The written plan for recovery

shall include:

Planning and preparation for a disaster;

Procedures for response to a disaster;

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Procedures for the maintenance and testing of the written plan for recovery; and

A procedure to notify the Board, each organization which has contracted with the

pharmacy, each patient of the pharmacy, and other appropriate agencies, of a

disaster and the date on which the pharmacy expects to recommence the provision of

service.

13:39-10.8 WRITTEN PROGRAM FOR PREVENTATIVE MAINTENANCE OF

AUTOMATED MEDICATION SYSTEM

A pharmacy which uses an automated medication system to fill prescriptions or medication

orders shall maintain a written program for preventative maintenance of the system.

SUBCHAPTER 11.

COMPOUNDING STERILE PREPARATIONS IN RETAIL AND

INSTITUTIONAL PHARMACIES

13:39-11.1 PURPOSE AND SCOPE

The rules in this subchapter regulate the practice of sterile compounding and shall apply to

all retail and institutional pharmacies that compound and dispense sterile preparations. This

subchapter establishes standards for the quality and control of processes, components, and

environments associated with compounded sterile preparations and for the skill and knowledge

of pharmacy personnel who prepare compounded sterile preparations.

13:39-11.2 DEFINITIONS

The following words and terms, when used in this subchapter, shall have the following

meanings:

“Ante area” means an ISO class 8 or better area where personnel hand hygiene and garbing

procedures, staging of components, order entry, labeling, and other high-particulate-generating

activities are performed. The “ante area” is also a transition area that:

1) Provides assurance that pressure relationships are constantly maintained so that air flows

from clean to dirty areas; and

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2) Reduces the need for the heating, ventilating, and air-conditioning (HVAC) control system

to respond to large disturbances.

“Biological safety cabinet” means a ventilated cabinet for compounded sterile preparations

that has an open front with inward airflow for personnel protection, downward high-efficiency

particulate air (HEPA)-filtered laminar airflow for product protection, and HEPA-filtered exhaust

air for environmental protection.

“Buffer area” means an ISO class 7 area where the primary engineering control is physically

located and where the preparation and staging of components and supplies used in

compounding sterile preparations occurs.

“Cleanroom” means a room in which the concentration of airborne particles is controlled to

meet a specified airborne particulate cleanliness (ISO) class. Microorganisms in the

environment are monitored, so that a microbial level for air, surface, and personnel gear are not

exceeded for a specified cleanliness class. A “cleanroom” includes a buffer area or room and an

ante area or room.

"Compounding" means the preparation, mixing, assembling, packaging, or labeling of a drug

or device as the result of a practitioner's prescription or medication order or initiative based on

the relationship of the practitioner or the patient with the pharmacist in the course of professional

practice, or for the purpose of, or incident to, research, teaching, or chemical analysis and not

for sale or dispensing. Compounding also includes the preparation of drugs or devices in

anticipation of prescriptions or medication orders based on routine, regularly-observed

prescribing patterns. Compounding includes mixing, reconstituting, or assembling a drug

according to the product’s labeling or to the manufacturer’s directions.

“Compounding aseptic containment isolator” means a compounding aseptic isolator

designed to provide worker protection from exposure to undesirable levels of airborne hazardous

drugs throughout the compounding and material transfer processes and to provide an aseptic

environment for compounding sterile preparations. Air exchange with the surrounding

environment should not occur unless the air is first passed through a microbial retentive filter

(high-efficiency particulate air (HEPA) minimum) system capable of containing airborne

concentrations of the physical size and state of the drug being compounded.

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“Compounding aseptic isolator” means a form of isolator specifically designed for

compounding pharmaceutical ingredients or preparations. It is designed to maintain an aseptic

compounding environment within the isolator throughout the compounding and material transfer

process. Air exchanges into the isolator from the surrounding environment should not occur

unless the air has first passed through a microbially retentive filter (high-efficiency particulate air

(HEPA) minimum).

“Immediate use compounded sterile preparations” means preparations intended for

emergency patient care and involve only simple aseptic measuring and transfer manipulations of

no more than three sterile non-hazardous commercial drug and diagnostic radiopharmaceutical

drug products, including an infusion or diluent solution. Unless required for the preparation, the

compounding process occurs continuously without delays or interruptions and does not exceed

one hour. Administration of immediate use compounded sterile preparations shall begin within

one hour of preparation or the compounded sterile preparations shall be discarded. Immediate

use compounded sterile preparations shall not be compounded and stored for anticipated needs

and shall not be compounded as batch preparations. At no time during the compounding

process, nor prior to administration, are critical sites and ingredients of the compounded sterile

preparation directly exposed to contact contamination, such as human touch, cosmetic flakes, or

particulates, blood, human body substances, and non-sterile inanimate sources.

"ISO class 5 air quality conditions" means conditions in which the air particle count is no

greater than a total of 3,520 particles of 0.5 micrometers and larger per cubic meter of air (100

particles per cubic foot) that is supplied by high-efficiency particulate air (HEPA) or HEPA-

filtered air.

"ISO class 7 air quality conditions" means conditions in which the air particle count is no

greater than a total of 352,000 particles of 0.5 micrometers and larger per cubic meter of air

(10,000 particles per cubic foot) that is supplied by high-efficiency particulate air (HEPA) or

HEPA-filtered air.

“ISO class 8 air quality conditions” means conditions in which the air particle count is no

greater than a total of 3,520,000 particles of 0.5 micrometers and larger per cubic meter of air

(100,000 particles per cubic foot) that is supplied by high-efficiency particulate air (HEPA) or

HEPA-filtered air.

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“Negative pressure room” means a room that is at a lower pressure than the adjacent spaces

and, therefore, the net airflow is into the room.

“Positive pressure room” means a room that is at a higher pressure than the adjacent spaces

and, therefore, the net airflow is out of the room.

“Primary engineering control” means a device or room that provides an ISO class 5

environment for the exposure of critical sites when compounding sterile preparations. Such

devices include laminar airflow workbenches, biological safety cabinets, compounding aseptic

isolators, and compounding aseptic containment isolators.

“Risk levels for compounded sterile preparations” means the established classification for

compounded sterile preparations based on the potential for microbial, chemical, and physical

contamination of the preparations and are defined as follows:

1) “Low-risk level compounded sterile preparations” means preparations compounded with

aseptic manipulations entirely within ISO class 5 or better air quality using only sterile

ingredients, products, components, and devices. The compounding process involves only

assembling, transferring, measuring, and mixing, using no more than three commercially

manufactured sterile products, and not more than two entries into one sterile container or

package to make the compounded sterile preparations. The compounding process is limited to

aseptically opening ampules, penetrating sterile stoppers on vials with sterile needles and

syringes, and transferring sterile liquids in sterile syringes to sterile administration devices,

package containers of other sterile products, and containers for storage and dispensing.

2) “Medium-risk level compounded sterile preparations” means preparations compounded

under low-risk level conditions but which require multiple individual or small doses of sterile

products to be combined or pooled to prepare compounded sterile preparations that will be

administered either to multiple patients or to one patient on multiple occasions. The

compounding process includes complex aseptic manipulations other than single volume transfer,

and requires an unusually long duration, such as that required to complete dissolution or

homogeneous mixing.

3) “High-risk level compounded sterile preparations” means preparations compounded from

non-sterile ingredients or from ingredients that are incorporated using non-sterile equipment

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before terminal sterilization, or from commercially manufactured sterile products that lack

effective antimicrobial preservatives and whose preparation, transfer, sterilization, and

packaging is performed in air quality worse than ISO class 5 for more than one hour. Water-

containing preparations that are stored for more than six hours before terminal sterilization are

also classified as high-risk level compounded sterile preparations.

13:39-11.3 APPLICATION AND PRE-APPROVAL REQUIREMENTS FOR

COMPOUNDING STERILE PREPARATIONS

a) An applicant for a new pharmacy who wishes to compound sterile preparations shall

satisfy all pharmacy permit application requirements set forth in N.J.A.C. 13:39-4.1. As part

of the permit application, the applicant shall submit plans detailing the physical

arrangements necessary to ensure compliance with the requirements in this subchapter. An

applicant for a pharmacy permit shall not compound sterile preparations at the site until

receiving written approval from the Board to engage in such activities. Prior to issuing the

written approval, the Board shall conduct an inspection of the pharmacy to ensure

compliance with the requirements in this subchapter.

b) The holder of an existing pharmacy permit who wishes to compound sterile preparations

shall submit an amended pharmacy permit application to the Board. The amended

permit application shall contain plans detailing the physical arrangements necessary to

ensure compliance with the requirements in this subchapter. The holder of an existing

pharmacy permit shall not compound sterile preparations at the site until receiving written

approval from the Board to engage in such activities. Prior to issuing the written

approval, the Board shall conduct an inspection of the pharmacy to ensure compliance

with the requirements in this subchapter.

c) A pharmacy permit holder who is approved to compound sterile preparations shall notify

the Board at least 60 days in advance of any remodeling, change of location, or change

in size of the pharmacy cleanroom, consistent with the requirements of N.J.A.C. 13:39-

4.7 and 4.8. Such notification shall include the pharmacy’s remodeling or relocation

plans, as appropriate, the pharmacy’s interim plans for the continuation of sterile

compounding operations, which the Board shall review and approve, and the anticipated

date of completion. The pharmacy permit holder and the pharmacist-in-charge shall

ensure compliance with all requirements set forth in this subchapter while compounding

operations continue during the remodeling or relocation process. The pharmacy permit

holder shall notify the Board upon completion of the remodeling or relocation process, at

which time the Board shall inspect the premises.

d) A pharmacy holding an institutional permit that is approved to compound sterile

preparations and that intends to compound sterile preparations using a laminar airflow

workbench not located in a buffer area, as provided in N.J.A.C. 13:39-11.10, shall notify

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the Board at least 60 days in advance of its intention and of all locations where such

equipment will be installed. The pharmacy permit holder shall notify the Board upon

completion of such installation, at which time the Board shall inspect the equipment. The

pharmacy shall not utilize such equipment to compound sterile preparations until

receiving Board approval.

e) A pharmacy permit holder who is approved to compound sterile preparations and who

intends to utilize compounding aseptic isolators or compounding aseptic containment

isolators not located in a buffer area, as provided in N.J.A.C. 13:39-11.8, shall notify the

Board at least 60 days in advance of its intention and of all locations where such

equipment will be installed. The pharmacy permit holder shall notify the Board upon

completion of such installation, at which time the Board shall inspect the equipment. The

pharmacy shall not utilize such equipment to compound sterile preparations until

receiving Board approval.

f) Notwithstanding the requirements of (a) through (e) above, a pharmacy permit holder or

pharmacy applicant may compound sterile preparations for the sole purposes of process,

equipment, personnel, and environmental testing. Any sterile preparations compounded

for these purposes shall be destroyed.

g) Approval by the Board to dispense compounded sterile preparations shall be contingent

upon demonstration that, as is related to maintaining a sterile compounding environment,

all environmental control and processes have been tested and validated, and all

equipment has been certified, tested, and validated.

13:39-11.4 CLEANROOM: USE, ACCESS, LOCATION; TEMPERATURE; AIR

PRESSURE

a) The pharmacy shall have a designated area for sterile preparation compounding, known

as the “cleanroom.” A cleanroom shall be physically designed and environmentally

controlled to minimize airborne contamination from contacting critical sites. Critical sites

are locations that include any component or fluid pathway surfaces (for example, vial

septa, injection ports, beakers), openings (for example, opened ampules, needle hubs),

exposed and at risk of direct contact with air (for example, ambient room or HEPA-

filtered), moisture (for example, oral and mucosal secretions), or touch contamination. A

cleanroom shall include a buffer area and an ante area. The buffer area shall contain an

ISO class 5 or better primary engineering control, such as a laminar airflow workbench,

biological safety cabinet, compounding aseptic isolator, and/or compounding aseptic

containment isolator, unless the buffer area has ISO class 5 or better air quality.

b) All sterile compounding shall take place within the confines of the buffer area, except for

the following:

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Compounding in a compounding aseptic isolator or a compounding aseptic

containment isolator pursuant to N.J.A.C. 13:39-11.8;

Compounding in a laminar airflow workbench in an institutional pharmacy pursuant to

N.J.A.C. 13:39-11.10; and

Compounding immediate use compounded sterile preparations in an institutional

pharmacy pursuant to N.J.A.C. 13:39-11.11.

c) A cleanroom shall be:

Accessible only to designated personnel;

Used only for the compounding of sterile preparations or such other tasks that require

a cleanroom;

Structurally isolated from other areas within the pharmacy by means of restricted

entry or access; and

Air conditioned to maintain a temperature of 59 to 77 degrees Fahrenheit with an

ideal temperature of 66 degrees Fahrenheit.

d) A pressure indicator or air velocity meter shall be installed that can be readily monitored

for correct room pressurization or air velocity, respectively, consistent with the following:

For compounding of non-hazardous drugs, if the buffer area and the ante area are

physically separated through the use of walls, doors, and pass-throughs, a minimum

differential positive pressure of 0.02 inch to 0.05 inch water column shall be required.

For buffer areas not physically separated from the ante area, the principle of

displacement airflow shall be employed. Using displacement airflow, an air velocity

of 40 feet per minute or more from the buffer area across the line of demarcation into

the ante area is required.

For compounding of antineoplastic agents and other hazardous substances, the

standards set forth in N.J.A.C. 13:39-11B.

e) No chewing gum, drinks, candy, or food items shall be brought into the cleanroom.

13:39-11.5 CLEANROOM REQUIREMENTS

a) The surfaces of ceilings, walls, floors, fixtures, shelving, counters, and cabinets in the

cleanroom shall be smooth, impervious, free from cracks and crevices, and nonshedding,

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thereby minimizing spaces in which microorganisms and other contaminants may

accumulate.

b) Work surfaces shall be constructed of smooth, impervious materials, such as stainless

steel or molded plastic, so that the work surfaces may be readily cleaned and sanitized.

All work surfaces shall be resistant to damage from cleaning and sanitizing agents.

c) Junctures where ceilings meet walls shall be covered, caulked, or sealed to avoid cracks

and crevices in which microorganisms and other contaminates can accumulate. All areas

in ceilings and walls where the surface has been penetrated shall be sealed.

d) Ceilings that consist of inlaid panels shall be impregnated with a polymer to render them

impervious and hydrophobic and shall either be caulked or weighted and clipped.

e) Walls shall be constructed of flexible material (for example, heavy gauge polymer),

panels locked together and sealed, or of epoxy-coated gypsum board.

f) Floors shall have a covering that shall be seamless or have heat-welded seams and

coving to the sidewall. There shall be no floor drains.

g) There shall be no dust-collection overhangs (such as ceiling utility pipes) and ledges

(such as window sills) shall be avoided. All sprinkler heads shall be flush with the ceiling.

h) Ceiling lighting fixtures shall have exterior lens surfaces which are smooth, mounted

flush, and air tight.

i) Carts shall be of stainless steel wire, nonporous plastic, or sheet metal construction with

good quality, cleanable casters to promote mobility.

j) Refrigerators shall be within, or reasonably accessible to, the cleanroom in order to

ensure the integrity of the compounded sterile preparations, consistent with the

requirements of N.J.A.C. 13:39-11.12(b)3.

13:39-11.6 ANTE AREA REQUIREMENTS

a) The ante area shall have appropriate environmental control devices capable of

maintaining ISO class 8 air quality conditions for non-hazardous drug compounding

activities.

b) The ante area shall contain the following equipment:

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A sink with hot and cold running water with an integrated and closed plumbing

system;

Waste containers for all personal protective equipment;

An eyewash station; and

A hazardous waste spill kit.

c) The ante room shall continuously maintain ISO Class 8 air quality under dynamic

conditions.

13:39-11.7 BUFFER AREA REQUIREMENTS

a) The buffer area shall have appropriate environmental control devices capable of

maintaining ISO class 7 air quality conditions during normal activity consistent with the

requirements of N.J.A.C. 13:39-11.4(d).

b) The buffer area shall contain only the following:

Items such as furniture, equipment, supplies, and other materials that are required for

the tasks to be performed there;

Items that are nonpermeable, nonshedding, cleanable, and resistant to damage from

disinfectants; and

Items that have been cleaned and disinfected immediately prior to their being placed

in the buffer area.

c) Equipment and other items used in the buffer area shall not be taken from these areas

except for calibration, servicing, or other activities associated with the proper

maintenance of the item.

d) The buffer area shall be kept clean and arranged in an orderly fashion. All required

equipment shall be maintained in good operating condition.

e) The buffer area shall not be used for bulk storage, warehousing, or clerical and

secretarial functions.

f) The buffer area shall not contain any sinks.

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g) The buffer area shall be a minimum of 100 square feet in size and shall continuously

maintain ISO Class 7 air quality under dynamic conditions.

h) The buffer area shall contain waste containers in compliance with Occupational Safety

and Health Administration (OSHA) standards for disposal of used needles and syringes

set forth in 29 CFR 1910.1030 and for disposal of chemotherapy waste set forth at 29

CFR 1910.1200, incorporated herein by reference, and available at www.osha.gov.

13:39-11.8 USE OF COMPOUNDING ASEPTIC ISOLATORS AND COMPOUNDING

ASEPTIC CONTAINMENT ISOLATORS LOCATED OUTSIDE OF A CLEANROOM

A pharmacy may utilize compounding aseptic isolators and compounding aseptic

containment isolators not located in a cleanroom to prepare compounded sterile preparations,

provided the compounding aseptic isolators and compounding aseptic containment isolators can

provide isolation from the room and maintain ISO class 5 air quality during dynamic operating

conditions, including transferring ingredients, components, and devices into and out of the

isolator and during preparation of compounded sterile preparations. Particle counts sampled

approximately six to 12 inches upstream of the critical exposure site must maintain ISO class 5

air quality levels during compounding operations. Compounding personnel shall obtain

documentation from the manufacturer that the compounding aseptic isolator or compounding

aseptic containment isolator will meet this standard when located in worse than ISO class 7

environments. A compounding aseptic isolator and compounding aseptic containment isolator

not located in a buffer area shall be located in an area that is maintained under sanitary

conditions and such area shall only be traveled by persons engaging in the compounding of

sterile preparations.

13:39-11.9 (RESERVED)

13:39-11.10 INSTITUTIONAL PHARMACY USE OF AIRFLOW WORKBENCHES NOT

IN A BUFFER AREA FOR LOW-RISK LEVEL COMPOUNDED STERILE

PREPARATIONS

A pharmacy holding an institutional pharmacy permit may utilize ISO class 5 laminar airflow

workbenches not located in a buffer area to prepare low-risk level compounded sterile

preparations provided that the administration of such preparations commences within 12 hours

of the preparation or as recommended by the manufacturer, whichever is less. Such

workbenches shall be located in an area which is maintained under sanitary conditions and

which is traveled only by persons engaging in the compounding of sterile preparations. Such

workbenches shall not be in a location that has unsealed windows or doors that connect to the

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outdoors or high traffic flow, or that is adjacent to areas including, but not limited to, construction

sites, warehouses, or food preparation. Sinks may not be located adjacent to the ISO class 5

workbench environments and must be separated from the immediate area of ISO class 5

workbenches. Personnel engaged in sterile compounding in such areas shall follow the

procedures relating to cleansing and garbing set forth in N.J.A.C. 13:39-11.14.

13:39-11.11 COMPOUNDING IMMEDIATE USE COMPOUNDED STERILE

PREPARATIONS IN AN INSTITUTIONAL PHARMACY

A pharmacy holding an institutional pharmacy permit may prepare non-hazardous immediate

use compounded sterile preparations outside of an ISO class 5 laminar airflow workbench when

the delay resulting from the use of the workbench would harm the patient, including situations in

which the patient experiences a sudden change in clinical status.

13:39-11.12 PHARMACIST-IN-CHARGE RESPONSIBILITIES

a) The pharmacist-in-charge shall supervise all sterile compounding performed by

pharmacy personnel. The pharmacist-in-charge shall be trained in aseptic manipulation

skills.

b) The pharmacist-in-charge shall be responsible for, at a minimum, the following:

Determining the procedural, environmental, and quality control practices that are

necessary for the risk levels he or she assigns to specific compounded sterile

preparations;

Ensuring that the selected sterilization method both sterilizes and maintains the

strength, purity, quality, and packaging integrity of the compounded sterile

preparations;

Ensuring the placement in buffer areas and ante areas of equipment (for example,

refrigerators), devices (for example, computers and printers) and objects (for

example, carts and cabinets) that are not essential to compounding is dictated by

their effect on the required environmental quality of air atmospheres and surfaces,

which shall be verified by monitoring;

Storage of all materials pertinent to the compounding of sterile preparations,

including drugs, chemicals, and biologicals, and the establishment of specific

procedures for procurement of the materials in accordance with State and Federal

laws and regulations;

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Ensuring that all packaging and labeling of all compounded sterile preparations in the

pharmacy are performed under the immediate personal supervision of a pharmacist;

Ensuring that preparation and compounding of sterile preparations is performed only

by pharmacists who have been trained in aseptic manipulation skills, or by pharmacy

technicians, pharmacy interns or pharmacy externs who have been trained in aseptic

manipulation skills working under the immediate personal supervision of a pharmacist

trained in aseptic manipulation skills;

Recording all transactions of the pharmacy as may be necessary under applicable

State, Federal, and local laws and rules, to maintain accurate control over, and

accountability for, all pharmaceutical materials, and ensuring that policies and

procedures exist with respect to the maintenance of the audit trail required pursuant

to N.J.A.C. 13:39-11.20;

Ensuring that all pharmacists, pharmacy technicians, pharmacy interns, and

pharmacy externs who compound sterile preparations are trained and evaluated

consistent with the requirements of N.J.A.C. 13:39-11.16;

Establishing procedures for maintaining the integrity of the product and the

manufacturer's control identity when repackaging sterile products. A pharmacist shall

check all repackaging and shall initial the repackaging records;

10)

Disposal of all unused drugs and materials used in compounding sterile preparations,

including antineoplastic agents and other hazardous substances, in accordance with

accepted professional standards, and the Medical Waste Act, N.J.S.A. 13:1E-48.1 et

seq., so as not to endanger the public health;

11)

Ensuring that the compounding area and its contents and other areas where

compounded sterile preparations are present are secured, so as to prevent access by

unauthorized personnel;

12)

Ensuring that the pharmacy contains, in addition to the minimum reference library

mandated in N.J.A.C. 13:39-5.8(a)1, the most recent edition of references pertinent

to compounding sterile preparations;

13)

Ensuring that records are maintained that document, at least twice daily, that

appropriate controlled cold (refrigerator), controlled freezer, if applicable, and

controlled room temperatures, as these terms are defined in United States

Pharmacopeia 797, are maintained. Such records shall be maintained for no less

than five years and shall be made available to the Board for inspection upon request;

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14)

Ensuring that all information required to be maintained as part of a pharmacy’s

patient profile record system pursuant to N.J.A.C. 13:39-7.19 or 9.19 is maintained

for all compounded sterile preparations;

15)

Ensuring that initial and ongoing multidisciplinary clinical monitoring and

comprehensive care plans are maintained and readily available; and

16)

Maintaining a policy and procedures manual detailing the pharmacy’s standard

operating procedures with regard to compounded sterile preparations, consistent with

the requirements of N.J.A.C. 13:39-11.23, ensuring compliance with such policies

and procedures, and maintaining a written quality assurance program, consistent with

the requirements of N.J.A.C. 13:39-11.24.

13:39-11.13 PHARMACY TECHNICIANS, PHARMACY INTERNS, AND PHARMACY

EXTERNS; REQUIRED SUPERVISION

a) Pharmacists shall provide immediate personal supervision to pharmacy technicians,

pharmacy interns, or pharmacy externs who are performing sterile compounding. The

ratio of pharmacists to pharmacy technicians shall not exceed 1:2 at any given time

unless all of the requirements of N.J.A.C. 13:39-6.15 are met.

Supervision shall include, but is not limited to, the checking of each ingredient used,

the quantity of each ingredient whether weighed, measured or counted, and the

finished label.

b) The pharmacist may delegate to pharmacy technicians, pharmacy interns, or pharmacy

externs only the following tasks: recording of the prescription, selection of the drugs,

container, and diluent, labeling, and compounding of preparations. The pharmacist shall

ensure that each task has been performed correctly.

13:39-11.14 PERSONNEL CLEANSING AND GARBING REQUIREMENTS

a) All personnel who engage in compounding sterile preparations shall comply with the

following requirements before entering the buffer area:

Personnel shall remove personal outer garments (for example, bandanas, coats,

hats, jackets, scarves, sweaters, vests), all cosmetics, and hand, wrist, and other

visible jewelry or piercings (for example, earrings, or lip or eyebrow piercings);

The wearing of artificial nails or extenders is prohibited while working in the

compounding area. Natural nails shall be kept neat and trimmed;

Personnel protective equipment shall be donned in the following order:

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i) Dedicated shoes or shoe covers;

ii) Head and facial hair covers (for example, beard covers in addition to face

masks);

iii) Face masks; and

iv) Eye shields, if required;

A hand and forearm cleansing procedure shall be performed. Personnel shall remove

debris from underneath fingernails using a nail cleaner under running warm water

followed by vigorous hand washing for at least 30 seconds. Hands and forearms to

the elbows shall be completely dried using either lint-free disposable towels or an

electric hand dryer; and

Personnel shall wear non-shedding gowns with sleeves that fit snugly around the

wrists and enclosed at the neck, that are designed for buffer area use.

b) Following the completion of all steps in (a) above, and once inside the buffer area,

personnel shall perform antiseptic hand cleansing, using a waterless alcohol-based

surgical hand scrub with persistent activity following manufacturers’ recommendations.

Once hands are dried thoroughly, personnel shall don sterile gloves. Gloves shall be

routinely inspected for holes, punctures, or tears, and shall be replaced immediately if

any are detected.

1) Gloves become contaminated when they make contact with non-sterile surfaces

during compounding activities. Disinfection of contaminated gloved hands may be

accomplished by wiping or rubbing sterile 70 percent Isopropyl Alcohol (IPA) on all

contact surface areas of the gloves and letting the gloved hands dry thoroughly.

Routine application of sterile 70 percent IPA shall occur throughout the compounding

process and whenever non-sterile surfaces (for example, vials, counter tops, chairs,

and carts) are touched.

c) When compounding personnel exit the cleanroom during a work shift, the exterior gown

may be removed and retained in the cleanroom if not visibly soiled, and may be re-

donned during that same work shift only. Shoe covers, hair and facial hair covers, face

masks/eye shields, and gloves, however, shall be replaced with new ones before re-

entering the buffer area, and proper hand hygiene shall be performed, consistent with (a)

and (b) above.

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13:39-11.15 CLEANING AND DISINFECTION REQUIREMENTS FOR CLEANROOM,

BUFFER AREA, AND ANTE AREA

a) The cleanroom, buffer area, and ante area shall be cleaned and disinfected consistent

with the following requirements:

1) All surfaces in laminar airflow workbenches, biological safety cabinets, compounding

aseptic isolators, and compounding aseptic containment isolators shall be cleaned

and disinfected at the beginning of each work shift, before each batch preparation is

started, after spills, and when surface contamination is known or suspected;

2) All counters, work surfaces, and floors shall be cleaned and disinfected daily; and

3) All walls, ceilings, and storage shelving shall be cleaned monthly.

b) All cleaning and disinfection shall be performed consistent with the standards established

in USP 797 Appendix II, which is incorporated herein by reference, as amended and

supplemented, and which is available for purchase at the United States Pharmacopeia

website, www.usp.org

13:39-11.16 TRAINING AND EVALUATION REQUIREMENTS

a) The pharmacist-in-charge and all pharmacists, pharmacy technicians, pharmacy interns,

and pharmacy externs involved in compounding sterile preparations shall have didactic

and practical training in sterile preparation compounding, including proper personnel

cleansing and garbing, and cleaning and disinfecting the sterile compounding areas,

cleanroom technology, laminar flow technology, isolator technology, if applicable, and

quality assurance techniques. Such training shall be documented for each person before

that individual begins to compound sterile preparations and annually thereafter for all

pharmacists, pharmacy technicians, pharmacy interns, and pharmacy externs who

compound sterile preparations. That documentation shall be maintained by the

permitholder for five years and made available to the Board upon request.

b) The pharmacist-in-charge shall be responsible for ensuring that, prior to compounding

sterile preparations and annually thereafter, all pharmacists, pharmacy technicians,

pharmacy interns, and pharmacy externs shall have passed a written test that

demonstrates competency in all areas set forth in (a) above, and in the pharmacy's

standard operating procedures with regard to compounding sterile preparations as set

forth in the policy and procedure manual required to be maintained pursuant to N.J.A.C.

13:39-11.23.

c) The pharmacist-in-charge shall be responsible for testing of the aseptic technique of all

pharmacists, pharmacy technicians, pharmacy interns, and pharmacy externs involved in

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compounding sterile preparations consistent with the methods set forth in USP 797

concerning “Aseptic Manipulation Competency Evaluation,” incorporated herein by

reference, as amended and supplemented, and which is available for purchase at the

United States Pharmacopeia website, www.usp.org

, prior to compounding sterile

preparations. Aseptic technique retesting shall be conducted annually for all personnel

engaged in compounding low- and medium-risk level preparations and semi-annually for

all personnel engaged in compounding high-risk level preparations.

d) All pharmacists, pharmacy technicians, pharmacy interns, and pharmacy externs

engaging in the compounding of sterile preparations shall successfully complete an initial

gloved fingertip/thumb sampling procedure prior to compounding sterile preparations.

Gloved fingertip/thumb sampling shall be conducted annually for all personnel engaged

in compounding low- and medium-risk level preparations and semi-annually for all

personnel engaged in compounding high-risk level preparations. All initial and

subsequent gloved fingertip/thumb sampling procedures shall be consistent with the

standards established in USP 797, which is incorporated herein by reference, as

amended and supplemented, and which is available for purchase at the United States

Pharmacopeia website, www.usp.org

e) Individuals who fail the written test and/or the test of aseptic technique shall be

prohibited from compounding sterile preparations until passing both tests.

f) All test results shall be maintained by the permit holder for five years and shall be made

available to the Board for inspection upon request.

13:39-11.17 BATCH PREPARATION

a) Pharmacists, pharmacy technicians, pharmacy interns, and pharmacy externs, consistent

with N.J.A.C. 13:39-11.13, may compound sterile preparations in a quantity that is

supported by prior valid prescriptions or medication orders before receiving a valid

written prescription or medication order, provided the pharmacist:

Documents a history of valid prescriptions or medication orders subsequently

received, within the beyond-use dating time of each product, which have been

generated solely within an established professional prescriber-patient-pharmacist

relationship;

Maintains the prescription or medication order on file for all such products dispensed

at the pharmacy;

Documents the batch preparation process, including selection of the drugs,

containers, and diluents, lot numbers and expiration dates of the drugs, containers

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and diluents, if any, and verification that the compounded sterile preparation has

been visually inspected to ensure the absence of particulate matter in solutions, the

absence of leakage from vials and bags, and the accuracy and thoroughness of

labeling. Each batch shall be given a unique batch number to identify the specific

batch; and

Ensures that the labeling requirements set forth at N.J.A.C. 13:39-11.21(a)1, 5, 7, 9,

and 10 are satisfied.

b) Pharmacists, pharmacy technicians, pharmacy interns, and pharmacy externs shall not

batch prepare compounded sterile preparations for human use without a prescription for

a licensed prescriber to use in his or her practice, except to the extent permitted by

Federal law. Anyone batch preparing compounds for non-human use without a

prescription pursuant to this section shall comply with all requirements of N.J.A.C. 13:39-

11.18 and the documentation requirements of N.J.A.C. 13:39-11.20(c).

13:39-11.18 COMPOUNDED STERILE PREPARATIONS FOR PRESCRIBER

PRACTICE USE

In the absence of a valid patient-specific prescription or medication order, pharmacists,

pharmacy technicians, pharmacy interns, and pharmacy externs shall not prepare compounded

sterile preparations for human use for a licensed prescriber to use in his or her practice, except

to the extent permitted by Federal law. A pharmacy may prepare compounded sterile

preparations for a licensed prescriber for non-human use in the prescriber's practice without a

prescription consistent with State and Federal laws pertinent to the prescriber’s health care

practice.

13:39-11.19 STABILITY AND STERILITY CRITERIA AND BEYOND-USE DATING

a) For purposes of this section, stability means the extent to which a preparation retains,

within specified limits and throughout its period of storage and use, the same properties

and characteristics that it possessed at the time of compounding.

b) In the absence of supporting valid scientific sterility testing and stability information that

is directly applicable to specific preparations, the following dates and times for storage

and initiation of administration of the compounded sterile preparations shall apply,

according to the assigned risk level of the preparation, unless the manufacturer’s

package indicates a different stability time:

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For low-risk level compounded sterile preparations, in the absence of passing a

sterility test:

i) Administration shall begin within 48 hours when the preparation is stored at

controlled room temperature (20 degrees Celsius to 25 degrees Celsius);

ii) Administration shall begin within 14 days when the preparation is stored at cold

temperatures (two degrees Celsius to eight degrees Celsius);

iii) Administration shall begin within 45 days when the preparation is stored in a

solid frozen state (-20 degrees Celsius); and

iv) For products prepared in an airflow workbench not located in a buffer area in

accordance with N.J.A.C. 13:39-11.10, administration shall begin within 12 hours or less

of preparation;

For medium-risk level compounded sterile preparations, in the absence of passing a

sterility test:

i) Administration shall begin within 30 hours when the preparation is stored at

controlled room temperature (20 degrees Celsius to 25 degrees Celsius);

ii) Administration shall begin within nine days when the preparation is stored at

cold temperatures (two degrees Celsius to eight degrees Celsius); and

iii) Administration shall begin within 45 days when the preparation is stored in a

solid frozen state (-20 degrees Celsius);

For high-risk level compounded sterile preparations, in the absence of passing a

sterility test:

i) Administration shall begin within 24 hours when the preparation is stored at

controlled room temperature (20 degrees Celsius to 25 degrees Celsius);

ii) Administration shall begin within three days when the preparation is stored at cold

temperatures (two degrees Celsius to eight degrees Celsius); and

iii) Administration shall begin within 45 days when the preparation is stored in a solid

frozen state (-20 degrees Celsius); and

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For immediate use compounded sterile preparations, administration shall begin no

less than one hour following the start of preparing the compounded sterile

preparation.

c) The administration dates and times established in (b) above shall not be exceeded or

extended for compounded sterile preparations without verifiable supporting valid

scientific sterility and stability information that is directly applicable to the specific

preparation or compound.

d) A pharmacist shall determine the beyond-use date for a compounded sterile preparation

consistent with (b) above and assign an appropriate discard-after date for the

compounded sterile preparation. The discard-after date shall appear on the label

consistent with the requirements of N.J.A.C. 13:39-11.21.

e) Opened or needle-punctured single-dose containers of sterile products (for example,

bags, bottles, syringes, and vials) used in the compounding of sterile preparations for

immediate use in an institutional pharmacy pursuant to N.J.A.C. 13:39-11.11, shall be

used within one hour if opened in worse than ISO Class 5 air quality, and any remaining

contents shall be discarded.

f) Single-dose vials used in the compounding of sterile preparations exposed to ISO Class

5 or cleaner air quality may be used up to six hours after initial puncture.

g) Opened single-dose ampules used in the compounding of sterile preparations shall not

be stored for any period of time.

h) Opened or needle-punctured multiple-dose vials used in the compounding of sterile

preparations shall be used within 28 days after initially entering the vial, unless otherwise

specified by the manufacturer.

13:39-11.20 DOCUMENTATION; AUDIT TRAIL

a) The pharmacist shall ensure that compounded sterile preparations have been properly

prepared, consistent with the assigned risk level of the preparation, labeled, controlled,

stored, dispensed, and distributed in accordance with the provisions of this subchapter.

The pharmacist shall be responsible for the accuracy and appropriateness of the

compounded prescription. When more than one pharmacist is involved in the steps of the

compounding process, the pharmacist shall be responsible for the accuracy and

appropriateness of each step he or she performed or he or she approved and reviewed,

and his or her unique and secure user identifier(s) shall be recorded in the audit trail.

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b) A pharmacy shall maintain an audit trail for all compounded sterile preparations

consistent with the requirements of N.J.A.C. 13:39-7.6.

c) A pharmacy shall maintain a compounding record for each compounded sterile

preparation that contains the following information:

Selection of the drugs, container, and diluent prior to their being compounded,

including documentation of lot numbers and expiration dates of the drugs, containers,

and diluents, if applicable;

Verification that ingredients comply with the prescription or medication order;

Verification that the prescription or medication order label complies with the

requirements of N.J.A.C. 13:39-11.21;

Verification that the compounded sterile preparation has been visually inspected to

ensure the absence of particulate matter in solutions, the absence of leakage from

vials and bags, and the accuracy and thoroughness of labeling; and

Verification that the prescription or medication order is complete and ready to be

dispensed, including any necessary ancillary supplies.

13:39-11.21 INFORMATION REQUIRED TO APPEAR ON PRESCRIPTION LABEL

a) The dispensed container for any compounded sterile preparation shall bear a

permanently affixed label with at least the following information:

The date and the time prepared;

In the retail pharmacy only, the name of the prescriber;

The name of the patient;

Directions for use;

The name and strength or quantity of all active ingredients, and the name and

volume of the diluent, vehicle, and base solution(s), if applicable;

The name, address, and telephone number of the pharmacy;

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The phrase “use by” followed by the preparation’s use by date and time (if no time is

stated, it is presumed to be 11:59 P.M. of the stated use by date).

Any ancillary and cautionary instructions as needed;

As pertinent, a warning consistent with applicable Federal and State law, that

antineoplastic agents and other hazardous substances products are biohazardous;

10)

As pertinent, the requirements for proper storage; and

11)

In a retail pharmacy, for those medications not dispensed pursuant to the

requirements of N.J.A.C. 13:39-9, the prescription number.

b) For immediate use compounded sterile preparations, when the preparation is not

administered by the person who prepared it, or its administration is not witnessed by the

person who prepared it, the compounded sterile preparation shall be labeled consistent

with the requirements of (a) above and shall also include the name or identifier of the

person who prepared the compounded sterile preparation.

13:39-11.22 HANDLING, PACKAGING, AND DELIVERY

a) The pharmacy shall be responsible for the proper handling and packaging of

compounded sterile preparations for delivery from the pharmacy to the patient in order to

assure and maintain the integrity, efficacy, stability, and sterility of these preparations.

The pharmacist-in-charge shall ensure that:

Tamper-evident packaging is utilized;

Delivery is made from the pharmacy to the patient or patient care location within a

reasonable time; and

Proper in-transit storage is provided consistent with product labeling.

13:39-11.23 POLICY AND PROCEDURES MANUAL

a) The pharmacy’s policy and procedures manual shall set forth in detail the pharmacy's

standard operating procedures with regard to compounded sterile preparations.

b) The policy and procedures manual shall include policies and procedures governing the

following:

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A risk-management program, including, but not limited to, documentation of incidents,

adverse drug reactions, and product contamination.

i) The risk-management program shall require that the pharmacist-in-charge report all

confirmed incidents of product contamination to the New Jersey Board of Pharmacy

within 48 hours of becoming aware of such incidents;

Security measures ensuring that the premises where compounded sterile drugs are

present are secured, so as to prevent access by unauthorized personnel;

Equipment;

i) Procedures for use; and

ii) Documentation of appropriate certifications;

Cleaning and disinfecting standards and procedures, consistent with the

requirements of N.J.A.C. 13:39-11.15;

Reference materials as set out in N.J.A.C. 13:39-5.8 and 11.12(b)12;

Information concerning drug:

i) Preparation;

ii) Storage and handling;

iii) Dispensing;

iv) Labeling;

v) Delivery; and

vi) Destruction, recalls and returns;

Patient recordkeeping as set forth in N.J.A.C. 13:39-11.12(b)14;

Handling, dispensing and documentation of investigational new drugs;

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A quality assurance program as set forth in N.J.A.C. 13:39-11.24;

10)

Verification of training and competency guidelines as set forth in N.J.A.C. 13:39-

11.16;

11)

Compounding process validation;

12)

Documentation as set forth in N.J.A.C. 13:39-11.20;

13)

Description of appropriate garb and garbing procedures, consistent with the

requirements of N.J.A.C. 13:39-11.14;

14)

Conduct guidelines for personnel in the cleanroom;

15)

Personnel responsibilities;

16)

Patient education;

17)

Protocol and procedures to maintain the integrity of the interior work area of the

laminar airflow workbenches, compounding aseptic isolators, compounding aseptic

containment isolators, and biological safety cabinets; and

18)

Written procedures in compliance with the Occupational Safety and Health

Administration standards for handling small and large spills of antineoplastic agents

and other hazardous substances.

c) The policy and procedures manual shall be reviewed, at a minimum, once every 24

months and shall be updated, on a continuous basis, to reflect current practice.

Documentation of the review shall be made available to the Board upon request.

13:39-11.24 QUALITY ASSURANCE PROGRAM

a) The pharmacy’s quality assurance program shall require, at a minimum, that:

A reasonable effort shall be made by the pharmacist to assure that compounded

sterile preparations shall be kept under appropriate controlled conditions at the

location of use by providing adequate labeling and verbal or written instructions

regarding proper storage and administration as set forth by the product manufacturer,

with each compounded sterile preparation dispensed;

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The quality assurance program encompasses all phases of sterile compounding for

each unique type of compounded sterile preparation dispensed;

After the preparation of every admixture, the contents of the container are thoroughly

mixed and then visually inspected to ensure the absence of particulate matter in

solutions, the absence of leakage from vials and bags, or any other defects, and the

accuracy and thoroughness of labeling;

All pharmacists, pharmacy technicians, pharmacy interns, and pharmacy externs

involved in compounding sterile preparations shall have their aseptic technique

tested consistent with the requirements of N.J.A.C. 13:39-11.16;

All high-risk level compounded sterile preparations that are prepared in groups of

more than 25 identical individual single-dose packages (for example, ampules, bags,

syringes, vials), or in multiple-dose vials for administration to multiple patients, or that

are exposed longer than 12 hours at two degrees to eight degrees Celsius and longer

than six hours at warmer than eight degrees Celsius before they are sterilized, and

all compounded sterile preparations whose beyond-use date has been exceeded,

shall be tested to ensure that they are sterile before they are dispensed or

administered. The USP membrane filtration method shall be used where feasible.

Another method may be used if verification results demonstrate that the alternative is

at least as effective and reliable as the membrane filtration method or the USP direct

inoculation of the culture medium method, consistent with the standards set forth in

USP 797 concerning “Sterility Testing,” 2012 edition, incorporated herein by

reference, as amended and supplemented, and available for purchase at the United

States Pharmacopeia website, www.usp.org

i. When high-risk level compounded sterile preparations are dispensed before

receiving the results of the sterility tests set forth in (a)5 above, the written quality

assurance procedure shall require daily observation of the incubating test

specimens and immediate recall of the dispensed compounded sterile

preparations when there is any evidence of microbial growth in the test

specimens. The patient and the physician of the patient to whom a potentially

contaminated compounded sterile preparation was administered shall be notified

immediately of the potential risk. Positive sterility tests shall require rapid and

systematic investigation of aseptic technique, environmental control, and other

sterility assurance controls in order to identify sources of contamination and to

take corrective action.

ii. All high-risk level compounded sterile preparations, except those for inhalation

and ophthalmic administration, shall be tested to ensure that they do not contain

excessive bacterial endotoxins;

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Air and surface sampling for microbial organisms in ISO class 5 primary engineering

controls, such as laminar airflow workbenches, compounding aseptic isolators,

compounding aseptic containment isolators, and biological safety cabinets, and in all

other ISO classified areas shall be certified by an independent certification company

once every six months and at any time when microbial contamination is suspected;

Pressure differential monitoring shall be conducted consistent with the requirements

of N.J.A.C. 13:39-11.4(d). A pressure gauge or velocity meter shall be installed to

monitor the pressure differential or airflow between the buffer area and the ante area

and between the ante area and the general environment outside the cleanroom. The

results shall be reviewed and documented on a log at least every work shift

(minimum frequency shall be at least daily) or by a continuous recording device;

Laminar airflow workbenches, compounding aseptic isolators, compounding aseptic

containment isolators, and biological safety cabinets shall be certified every six

months, and every time they are moved, by an independent certification company to

ensure that these primary engineering controls meet appropriate ISO classifications;

A cleanroom shall be certified by an independent certification company every six

months and whenever the room or a primary engineering control in the room is

relocated or altered, or whenever major service to the facility is performed, to ensure

that the cleanroom meets appropriate ISO classifications. Such certifications shall be

performed consistent with procedures outlined in the Controlled Environment Testing

Association (CETA) Certification Guide for Sterile Compounding Facilities (CAG-003-

2006) (revised December 8, 2008), incorporated herein by reference, as amended

and supplemented, and which may be found at the CETA website,

www.cetainternational.org

, specifically,

www.cetainternational.org/reference/CETAAsepticCompoundingCertificationGuide.pd

f; and

10)

Whenever test results indicate that the cleanroom or any primary engineering

controls do not meet the standards established in this section, the pharmacy shall

immediately cease using the cleanroom or primary engineering control that is out of

compliance until such time that the cleanroom and/or the primary engineering control

meets the requisite standards. The pharmacy shall notify the Board in writing within

48 hours of any air and/or surface sampling test results that are out of compliance.

Test results indicating non-compliance with the requisite standards shall require re-

evaluation of all procedures associated with the production of compounded sterile

preparations in the impacted cleanroom or primary engineering control and

documentation with respect to the period of time that the cleanroom and/or primary

engineering control was out of compliance.

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13:39-11.25 PROHIBITED COMPOUNDING

a) A pharmacist shall not compound preparations that contain drug products that appear on

the Federal Food and Drug Administration’s List of Drug Products Withdrawn or

Removed from the Market for Reasons of Safety or Effectiveness, codified at 21 CFR

216.24.

b) A pharmacist shall not compound any commercially available drug products unless:

The commercially available product is modified to produce a significant difference, in

the professional judgment of the prescriber, between the compounded product for the

patient and the comparable commercially available product; or

The commercially available product is not available from normal distribution channels

in a timely manner to meet the patient’s needs, and the dispensing of the

compounded product has been approved by the prescriber and the patient.

c) A pharmacist who compounds a commercially available product consistent with the

requirements of (b) above shall maintain documentation of the reason for such

compounding.

13:39-11.26 (RESERVED)

13:29-11.27 (RESERVED)

SUBCHAPTER 11A. COMPOUNDING NON-STERILE PREPARATIONS IN

RETAIL AND INSTITUTIONAL PHARMACIES

13:39-11A.1 PURPOSE AND SCOPE

The rules in this subchapter regulate the practice of non-sterile compounding and shall apply

to all retail and institutional pharmacies that compound and dispense non-sterile preparations.

This subchapter establishes standards for the quality and control of processes, components, and

environments associated with compounded non-sterile preparations, and for the skill and

knowledge of pharmacy personnel who prepare compounded non-sterile preparations. The

requirements in this subchapter establish minimum good compounding practices that will

enhance a pharmacist’s ability to compound non-sterile preparations that are of acceptable

strength, quality, and purity.

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13:39-11A.2 DEFINITIONS

The following words and terms, when used in this subchapter, shall have the following

meanings:

"Compounding" means the preparation, mixing, assembling, packaging, and labeling of a

drug or device as the result of a practitioner's prescription or medication order or initiative based

on the relationship of the practitioner or patient with the pharmacist in the course of professional

practice or for the purpose of, or incident to, research, teaching, or chemical analysis and not for

sale or dispensing. Compounding also includes the preparation of drugs or devices in

anticipation of prescriptions or medication orders based on routine, regularly observed,

prescribing patterns.

“Compounding pharmacist” means a pharmacist who performs or supervises any part of

the compounding process.

13:39-11A.3 PROHIBITED COMPOUNDING

a) A pharmacist shall not compound preparations that contain drug products that appear on

the Federal Food and Drug Administration’s list of Drug Products Withdrawn or Removed

from the Market for Reasons of Safety or Effectiveness, codified at 21 CFR 216.24.

b) A pharmacist shall not compound any commercially available drug products except as

provided in N.J.A.C. 13:39-11A.4.

13:39-11A.4 COMPOUNDING COMMERCIALLY AVAILABLE PRODUCTS

a) A pharmacist shall not compound commercially available products unless:

The commercially available product is modified to produce a significant difference, in

the professional judgment of the prescriber, between the compounded product for the

patient and the comparable commercially available product; or

The commercially available product is not available from normal distribution channels

in a timely manner to meet the patient’s needs, and the dispensing of the

compounded product has been approved by the prescriber and the patient.

b) A pharmacist who compounds a commercially available product consistent with the

requirements of (a) above shall maintain documentation of the reason for such

compounding.

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13:39-11A.5 BATCH PREPARATION

A pharmacist may compound non-sterile preparations in a quantity that is supported by prior

valid prescriptions or medication orders before receiving a valid written prescription or

medication order, provided the pharmacist can document a history of valid prescriptions

subsequently received shortly thereafter or medication orders that have been generated solely

within an established professional prescriber-patient-pharmacist relationship, and provided the

prescription or medication order is retained on file at the pharmacy, consistent with the

requirements of N.J.A.C. 13:39-7.19. The pharmacist shall document the batch preparation

process in accordance with the requirements of N.J.A.C. 13:39-11A.15.

13:39-11A.6 COMPOUNDED NON-STERILE PREPARATIONS FOR PRESCRIBER

PRACTICE USE

In the absence of a valid patient-specific prescription or medication order, pharmacists,

pharmacy technicians, pharmacy interns, and pharmacy externs shall not prepare compounded

non-sterile preparations for human use for a licensed prescriber to use in his or her practice,

except to the extent permitted by Federal law. A pharmacy may prepare compounded non-

sterile preparations for a licensed prescriber for non-human use in the prescriber's practice

without a prescription consistent with State and Federal laws pertinent to the prescriber’s health

care practice.

13:39-11A.7 PREPARATION OF PHARMACY GENERATED PRODUCTS (PGPS) FOR

OVER-THE-COUNTER SALE

a) A pharmacist may prepare a pharmacy generated product to be sold over-the-counter

without a prescription or medication order provided that:

The product does not contain an ingredient that exceeds allowable strengths and

doses for over-the-counter drugs; and

The finished product is not one for which a prescription or medication order is

required.

b) A finished product that is prepared pursuant to (a) above shall be properly labeled with

the following:

The product name;

The name of all ingredients;

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The strength or quantity of all active ingredients;

The package size;

Directions for use;

The use by date, consistent with the requirements of N.J.A.C 13:39-11A.11;

The name, address, and telephone number of the pharmacy;

Any ancillary and cautionary instructions, as needed; and

As pertinent, the requirements for proper storage.

c) A pharmacy generated product shall be sold directly to the consumer only after

professional interaction or consultation between a pharmacist and the consumer.

d) A pharmacy generated product shall be stored in such a manner as to be inaccessible to

the public.

e) A pharmacy generated product shall not be sold to any entity for resale purposes.

f) The preparation of pharmacy generated products shall be documented in accordance

with the requirements of N.J.A.C. 13:39-11A.15(b)1 and 6 through 14.

13:39-11A.8 COMPOUNDING AREA

a) A pharmacy that regularly engages in compounding shall have an area specifically

designated for the safe and orderly compounding of drug products. Such area shall

allow for the orderly placement of equipment and materials in order to minimize the

potential for errors.

b) A pharmacy that engages in occasional compounding shall prepare an area prior to each

compounding activity that allows for the safe and orderly compounding of drug products.

The area shall allow for the orderly placement of equipment and materials in order to

minimize the potential for errors.

c) A pharmacy engaged in compounding shall ensure that:

All compounding areas are well-lighted and ventilated and are maintained in a clean

and sanitary condition;

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Heating and air conditioning systems are controlled to avoid decomposition of

chemicals;

Sewage, trash, and other refuse in and from the pharmacy and immediate drug

compounding area are maintained, and disposed of, in a timely, safe, and sanitary

manner; and

The compounding area is easily accessible to hot and cold running water, exclusive

of the bathroom sink; soap or detergent; and air dryers or single source towels.

13:39-11A.9 EQUIPMENT AND SUPPLIES

a) A pharmacy shall possess equipment appropriate to the type of compounding performed

at the pharmacy.

b) Equipment used in compounding drug products shall be of appropriate design and

capacity, and shall be suitably located to facilitate operations for the intended use,

cleaning, and maintenance of the equipment.

c) Equipment used in compounding drug products shall be of suitable composition.

Equipment surfaces that contact components shall not be reactive, additive, or

adsorptive, so as to alter the safety, identity, strength, quality, and purity of the

compounded product.

d) Equipment used in compounding drug products shall be thoroughly cleaned and

sanitized after each use, and when necessary, prior to use, in order to prevent cross-

contamination of ingredients and preparations.

e) Equipment used in compounding drug products shall be stored in a manner to prevent

cross-contamination of ingredients and preparations.

f) Automated, mechanical, or electronic equipment may be used in compounding non-

sterile preparations. All equipment utilized in compounding non-sterile preparations shall

be inspected, maintained, and validated at appropriate intervals, consistent with

manufacturer’s recommendations, to ensure the accuracy and reliability of equipment

performance.

13:39-11A.10 RESPONSIBILITIES OF THE COMPOUNDING PHARMACIST;

REPORTING REQUIREMENT

a) A compounding pharmacist shall be responsible for the ensuring that:

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Compounded non-sterile preparations have been properly prepared, labeled,

controlled, stored, dispensed, and distributed in accordance with the provisions of

this subchapter;

All aspects of the compounding process set out in N.J.A.C. 13:39-11A.15 are

documented and that accurate compounding records for all compounded non-sterile

preparations prepared by the pharmacy are maintained;

Compounding personnel are capable of performing and qualified to perform their

assigned duties;

Ingredients used in compounding have their expected identity, quality, and purity

consistent with the requirements of N.J.A.C. 13:39-11A.12;

Compounded preparations are of acceptable strength, quality, and purity, with

appropriate packaging and labeling, and are prepared in accordance with good

compounding practices, official standards, and relevant scientific data and

information as set forth in USP 795, which is incorporated herein by reference, as

amended and supplemented, and which is available for purchase at the United States

Pharmacopeia website, www.usp.org

;

Critical processes are recorded and validated to ensure that procedures will

consistently result in the expected qualities in the finished preparation;

The compounding environment is suitable for its intended purpose;

Appropriate stability evaluation is performed or is determined from the literature for

establishing reliable beyond-use dating to ensure that the finished preparations have

their expected potency, purity, quality, and characteristics, at least until the labeled

beyond-use date;

Compounding conditions and procedures are in place to minimize the potential for

errors;

10)

Adequate procedures and records exist for investigating and correcting failures or

problems in compounding, testing, or in the preparation itself; and

11)

The patient is advised that the product dispensed is a compounded preparation.

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b) Any confirmed incidents of product contamination shall be reported by the pharmacist-in-

charge to the New Jersey Board of Pharmacy within 48 hours of becoming aware of any

such incidents.

13:39-11A.11 BEYOND-USE DATES

a) The beyond-use date is the date after which a compounded non-sterile preparation shall

not be used. The beyond-use date shall be determined from the date the preparation is

compounded. Because compounded preparations are intended for administration

immediately or following short-term storage, beyond-use dates may be assigned based

on criteria different from those applied to assigning expiration dates to manufactured

drug products.

b) In the absence of stability information that is applicable to a specific drug product and

preparation, the following are the maximum beyond-use dates for non-sterile

compounded drug preparations that are packaged in tight, light-resistant containers and

stored at controlled room temperature unless otherwise indicated:

For nonaqueous liquids and solid formulations:

i) Where the manufactured drug product is the source of the active ingredient, the

beyond-use date shall not be later than 25 percent of the time remaining until the

product’s expiration date or six months, whichever is earlier;

ii) Where a United States Pharmacopeia–National Formulary (USP–NF), analytical

reagent (AR), certified American Chemical Society (ACS), or Food Chemicals

Codex (FCC) grade substance is the source of the active ingredient, the beyond-

use date shall not be later than six months or the expiration date of the

ingredient, whichever is earlier; and

iii) Where there is more than one ingredient, the beyond-use date shall be no longer

than six months or the expiration date of the first ingredient to expire, whichever

is earlier;

For water-containing formulations (prepared from ingredients in solid form), the

beyond-use date shall not be later than 14 days for liquid preparations when stored at

cold temperatures between two degrees and eight degrees Celsius (36 degrees and

46 degrees Fahrenheit); and

For all other formulations, the beyond-use date shall not be later than the intended

duration of therapy or 30 days, whichever is earlier.

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c) The beyond-use date limits established in this section may be exceeded only when there

is supporting valid scientific stability information that is directly applicable to the specific

preparation (that is, the same drug concentration range, pH, excipients, vehicle, water

content, etc.).

13:39-11A.12 INGREDIENT SELECTION

a) All ingredients used to compound non-sterile preparations shall be United States

Pharmacopeia–National Formulary (USP–NF), analytical reagent (AR), certified

American Chemical Society (ACS), or Food Chemicals Codex (FCC) grade substances.

If a USP-NF, AR, ACS, or FCC grade substance ingredient is not available, the

pharmacist shall establish the purity and safety of the ingredient by reasonable means,

which may include lot analysis, manufacturer reputation, or reliability of source study.

b) A manufactured drug product may be utilized as the source of an active ingredient. Only

manufactured drug products from containers labeled with a batch control number and an

unexpired expiration date shall be utilized as sources of active ingredients. When

compounding with manufactured drug products, the compounding pharmacist shall

consider all ingredients present in the drug product relative to the intended use of the

compounded non-sterile preparation.

c) Components used in the compounding of non-sterile preparations such as aliquots,

triturates, stock solutions, buffering agents, or isotonic solutions may be prepared in

advance and stored as pharmacy stock. The preparation of such products shall be

documented in accordance with the requirements of N.J.A.C. 13:39-11A.15(b)1 and 6

through 14.

13:39-11A.13 INFORMATION REQUIRED TO APPEAR ON PRESCRIPTION LABEL

a) The dispensed container for any compounded non-sterile preparation shall bear a

permanently affixed label with at least the following information:

In a retail pharmacy only, the name of the prescriber.

i) An institutional pharmacy compounding non-sterile preparations for out-patient

use shall include the name of the prescriber on the label, consistent with the

labeling requirements for a retail pharmacy;

The name of the patient;

The name of all active ingredients;

Directions for use;

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The use by date, consistent with the requirements of N.J.A.C 13:39-11A.11;

The name, address, and telephone number of the pharmacy;

Any ancillary and cautionary instructions as needed; and

As pertinent, the requirements for proper storage.

13:39-11A.14 PHARMACY TECHNICIANS, PHARMACY INTERNS, AND PHARMACY

EXTERNS; REQUIRED SUPERVISION

a) The compounding pharmacist shall provide immediate personal supervision to pharmacy

technicians, pharmacy interns, or pharmacy externs who are performing non-sterile

preparation compounding.

Supervision shall include, but is not limited to, the checking of each ingredient used,

the quantity of each ingredient whether weighed, measured, or counted, and the

finished label.

b) The compounding pharmacist may delegate to pharmacy technicians, pharmacy interns,

or pharmacy externs only the following tasks: recording of the prescription, selection of

the drugs and container, typing of labels, and compounding of preparations. The

compounding pharmacist shall ensure that each task has been performed correctly.

13:39-11A.15 AUDIT TRAIL; COMPOUNDING RECORD DOCUMENTATION

a) A pharmacy shall maintain an audit trail for all non-sterile compounded preparation

prescriptions dispensed consistent with the requirements of N.J.A.C. 13:39-7.6.

b) Except as provided in (c) below, a pharmacy shall maintain a compounding record for

each compounded non-sterile preparation that contains the following information:

Selection of the ingredients and documentation of source, lot numbers, and

expiration dates of all ingredients used;

Verification that ingredients comply with the prescription or medication order;

Verification that the prescription or medication order label complies with the

requirements of N.J.A.C. 13:39-11A.13;

Verification that the prescription or medication order is complete and ready to be

dispensed, including any necessary ancillary supplies;

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Strength of preparation;

Date of preparation;

Name or personal identifier of the person(s) who performed each step of the

compounding process and the compounding pharmacist(s) who verified the

preparation;

Reference(s) for formulation, if available;

Total quantity;

10)

Detailed steps of the compounding process to ensure that the exact same compound

can be duplicated at a future date;

11)

Type of dispensing container used when a drug has specific storage requirements;

12)

Beyond-use date of the finished product consistent with the requirements in N.J.A.C.

13:39-11A.11;

13)

The assigned internal identification number for the preparation or the prescription

number; and

14)

Instructions for use, storage, and handling of the compounded preparation.

c) A compounding record shall not be required for:

Mixing, reconstituting, or assembling a drug according to the product’s labeling or the

manufacturer’s directions; and

Product flavoring.

SUBCHAPTER 11B. COMPOUNDING ANTINEOPLASTIC AGENTS AND

OTHER HAZARDOUS SUBSTANCES: STERILE AND NON-STERILE

PREPARATIONS

13:39-11B.1 PURPOSE AND SCOPE

a) The rules in this subchapter regulate the practice of compounding antineoplastic agents

and other hazardous substances for both sterile and non-sterile preparations and shall

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apply to all retail and institutional pharmacies that compound and dispense antineoplastic

agents and other hazardous substances. The rules in this subchapter supplement those

of N.J.A.C. 13:39-11 and 11A. To the extent the requirements for compounding

antineoplastic agents and other hazardous substances are not specifically addressed in

this subchapter, the requirements of N.J.A.C. 13:39-11 and 11A, as applicable, shall be

followed.

b) Effective on the effective date of USP 800 (currently, December 1,2019), the

compounding of antineoplastic agents and other hazardous substances shall be

consistent with the standards established in USP 800, which is incorporated herein by

reference, as amended and supplemented, and which is available for purchase at the

United States Pharmacopeia website, www.usp.org

13:39-11B.2 DEFINITIONS

a) The following words and terms, when used in this subchapter, shall have the following

meanings:

“Hazardous substances” shall mean those substances identified as hazardous by

the National Institute for Occupational Safety and Health (NIOSH) in NIOSH Publication

No. 2004-165: Preventing Occupational Exposure to Antineoplastic and Other Hazardous

Drugs in Health Care Settings, Appendix A (2012 Edition). The sample list of drugs that

shall be handled as hazardous (Appendix A) is incorporated herein by reference, as

amended and supplemented, and can be found at the Centers for Disease Control and

Prevention website, www.cdc.gov, specifically, www.cdc.gov/niosh/docs/2004-165/

b) Any term not defined in this section shall have the definition set forth in N.J.A.C. 13:39-

11.2.

13:39-11B.3 COMPOUNDING ANTINEOPLASTIC AGENTS AND OTHER

HAZARDOUS PRODUCTS: STERILE PREPARATIONS

a) Pharmacies shall not prepare antineoplastic agents and other hazardous substances as

immediate use compounded sterile preparations.

b) A pressure indicator or air velocity meter shall be installed that can be readily monitored

for correct room pressurization or air velocity, respectively, consistent with the following:

Effective up until the day before the effective date of USP 800 (currently, November

30, 2019), for compounding of antineoplastic agents and other hazardous substances

in a cleanroom pursuant to N.J.A.C. 13:39-11.9, the primary engineering control shall

be placed in an ISO class 7 buffer room that is physically separated from other

preparation areas and has not less than 0.01 inch water column negative pressure to

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adjacent positive pressure ISO class 7 or better ante room, thus providing inward

airflow to contain any airborne drug. Effective on the effective date of USP 800

(currently, December 1, 2019), for compounding of antineoplastic agents and other

hazardous substances in a cleanroom pursuant to N.J.A.C. 13:39-11.9, the primary

engineering control shall be placed consistent with the standards set forth in USP

800.

Effective up until the day before the effective date of USP 800 (currently, November

30, 2019), for compounding of antineoplastic agents and other hazardous substances

outside of a cleanroom pursuant to N.J.A.C. 13:39-11.8, if a compounding aseptic

containment isolator is used outside of a buffer area, the compounding area shall be

physically separated from other areas and shall maintain a minimum negative

pressure of 0.01 inch water column and have a minimum of 12 air exchanges per

hour. Effective on the effective date of USP 800 (currently, December 1, 2019), for

compounding of antineoplastic agents and other hazardous substances outside of a

cleanroom pursuant to N.J.A.C. 13:39-11.8, if a compounding aseptic containment

isolator is used outside of a buffer area, the compounding area shall meet the

standards set forth in USP 800.

c) The ante area shall have appropriate environmental control devices capable of

maintaining ISO class 7 air quality conditions for hazardous drug compounding activities

as provided in (b)1 above.

d) A pharmacy utilizing a compounding aseptic containment isolator not located in a

cleanroom to compound antineoplastic agents and other hazardous substances shall

comply with the requirements of (b)2 above.

e) Effective up until the day before the effective date of USP 800 (currently, November 30,

2019), pharmacies shall compound antineoplastic agents and other hazardous

substances only in:

A compounding aseptic containment isolator or a Class II or Class III biological safety

cabinet in a negative pressure cleanroom. When handling volatile hazardous drugs,

such devices shall be vented to the outside air; or

A compounding aseptic containment isolator located outside of a negative pressure

cleanroom, consistent with N.J.A.C. 13:39-11.8. When handling volatile hazardous

drugs, such devices shall be vented to the outside air.

f) Effective on the effective date of USP 800 (currently, December 1, 2019), pharmacies

shall compound antineoplastic agents and other hazardous substances consistent with

the standards set forth in USP 800.

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g) Personnel who compound and dispense antineoplastic agents and other hazardous

substances shall adhere to standards established by the Occupational Health and Safety

Administration (OSHA) set forth in Section VI, Chapter 2 of OSHA’s Technical Manual on

Controlling Occupational Exposure to Hazardous Drugs (effective date January 20,

1999). OSHA’s Technical Manual is incorporated herein by reference, as amended and

supplemented, and can be found at the OSHA website, www.osha.gov

, specifically,

www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html. Personnel shall also comply with the

standards established by NIOSH in NIOSH Publication No. 2004-165: Preventing

Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care

Settings. The NIOSH Publication No. 2004-165 (2012 Edition) is incorporated herein by

reference, as amended and supplemented, and can be found at the CDC website,

www.cdc.gov, specifically, www.cdc.gov/niosh/docs/2004-165/. Effective on the effective

date of USP 800 (currently, December 1, 2019), personnel shall also comply with the

standards set forth in USP 800.

h) Antineoplastic agents and other hazardous substances used to compound sterile

preparations shall be stored separately from other inventory in a manner to prevent

contamination and personnel exposure. Such storage is preferable within a containment

area, such as a negative pressure room. The storage area shall have sufficient general

exhaust, at least 12 air exchanges per hour to dilute and remove any airborne

contaminants. Antineoplastic agents and hazardous substances used to compound

sterile preparations shall be handled with caution using appropriate chemotherapy gloves

during distribution, receiving, stocking, inventorying, preparing for administration, and

disposal.

i) Effective on the effective date of USP 800 (currently, December 1, 2019), antineoplastic

agents and other hazardous substances used to compound sterile preparations shall be

stored and handled consistent with the standards set forth in USP 800.

13:39-11B.4 COMPOUNDING ANTINEOPLASTIC AGENTS AND OTHER

HAZARDOUS PRODUCTS: NON-STERILE PREPARATIONS

When antineoplastic agents and hazardous substances are utilized in the compounding of

non-sterile preparations, a pharmacy shall adhere to standards established by the Occupational

Health and Safety Administration (OSHA) set forth in Section VI, Chapter 2 of OSHA’s Technical

Manual on Controlling Occupational Exposure to Hazardous Drugs (effective date January 20,

1999). OSHA’s Technical Manual is incorporated herein by reference, as amended and

supplemented, and can be found at the OSHA website, www.osha.gov

, specifically,

www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html. Personnel shall also comply with the

standards established by National Institute for Occupational Safety and Health (NIOSH) in

NIOSH Publication No. 2004-165: Preventing Occupational Exposure to Antineoplastic and

Other Hazardous Drugs in Health Care Settings. The NIOSH standard is incorporated herein by

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reference, as amended and supplemented, and can be found at the CDC website, www.cdc.gov,

specifically, www.cdc.gov/niosh/docs/2004-165/. Effective on the effective date of USP 800

(currently, December 1, 2019), personnel shall also comply with the standards set forth in USP

800.

SUBCHAPTER 12.

NUCLEAR PHARMACIES

13:39-12.1 DEFINITIONS

The following words and terms when used in this subchapter shall have the following

meanings, unless the context clearly indicates otherwise.

"Authentication of product history" includes, but is not limited to, identifying the purchase

source, the ultimate use or disposition and any intermediate handling of any components of a

radiopharmaceutical.

"Authorized practitioner" means a practitioner duly authorized by applicable Federal and

State law to possess, use and administer radiopharmaceuticals.

"Designated agent" means an individual under the direct supervision of a practitioner

authorized to communicate the practitioner's instructions to the nuclear pharmacy.

"Immediate personal supervision" means that the pharmacist is physically present in the

compounding/dispensing area when interns, externs and pharmacy technicians are performing

delegated duties, and the pharmacist conducts any necessary in-process checks and the final

check in preparation and compounding of medications, including the checking of each ingredient

used, the quantity of each ingredient whether weighed, measured or counted, and the finished

label.

"Internal test assessment" includes, but is not limited to, conducting those tests necessary to

insure the integrity of the test.

"Radiopharmaceutical" means any substance defined as a drug in Section 201(g)(1) of the

Federal Food, Drug and Cosmetic Act or in the FDA's Nuclear Pharmacy Guidelines and which

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exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or

photons and includes any such drug which is intended to be made radioactive. This definition

includes nuclide generators which are intended to be used in the preparation of any such

substance but does not include drugs such as carbon-containing compounds or potassium-

containing compounds or potassium-containing salts which contain trace quantities of naturally

occurring radionuclides.

"Radiopharmaceutical quality assurance" includes, but is not limited to, the performance of

appropriate chemical, biological and physical tests on radiopharmaceuticals and the

interpretation of the resulting data to determine their suitability for use in humans and animals,

including internal test assessment, authentication of product history and the keeping of proper

records.

"Radiopharmaceutical service" includes, but is not limited to, the compounding, dispensing,

labeling and delivery of radiopharmaceuticals; the participation in radiopharmaceutical utilization

reviews; the proper and safe storage and distribution of radiopharmaceuticals; the maintenance

of radiopharmaceutical quality assurance; and the offering of those acts, services, operations or

transactions necessary in the conduct, operation, management and control of a nuclear

pharmacy.

13:39-12.2 GENERAL REQUIREMENTS FOR PHARMACIES PROVIDING

RADIOPHARMACEUTICAL SERVICE

a) The application for a specialized retail permit to operate a pharmacy providing

radiopharmaceutical services shall only be issued to a site employing a qualified nuclear

pharmacist. All personnel performing tasks in the preparing and distribution of drugs shall

be under the immediate personal supervision of the nuclear pharmacist who shall be

responsible for all nuclear operations of the licensed area and shall be in personal

attendance at all times when the nuclear pharmacy is open for business. Nuclear

pharmacies shall maintain an audit trail that records and documents the unique and

secure user identifier(s) of the pharmacist(s), pharmacy technician(s), intern(s) or

extern(s) performing the radiopharmaceutical services, which are required to be

performed by a pharmacist, pharmacy technician, intern or extern pursuant to the

requirements of this chapter. The collection of demographic information for the patient

profile as provided for in N.J.A.C. 13:39-6.15(a)2i is not required to be, but may be,

recorded in the audit trail. All entries to the audit trail made by a pharmacy technician,

intern or extern shall be reviewed and approved by the pharmacist. The pharmacist shall

be responsible for the accuracy and appropriateness of the radiopharmaceutical services

performed. When more than one pharmacist is involved in performing

radiopharmaceutical services pursuant to this subchapter, each pharmacist shall be

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responsible for the accuracy and appropriateness of the radiopharmaceutical services he

or she performed or reviewed and approved, and his or her unique and secure user

identifier(s) shall be recorded in the audit trail. Audit trail documentation shall be

generated at the time each service is performed. Such documentation shall be

maintained or stored in original hard copy form or in any other media that facilitates the

reproduction of the original hard copy and shall be kept by the pharmacy for five years.

The oldest four years of information shall be maintained in such a manner so as to be

retrievable and readable within two weeks. The most recent one year of information shall

be retrievable and readable within one business day. Records not currently in use need

not be stored in the pharmacy, but off-site facilities used to store such records shall be

secure. Patient records shall be kept confidential, but shall be made available to persons

authorized to inspect them under State and Federal statutes and regulations.

b) Nuclear pharmacies shall have adequate space, commensurate with the scope of

services required and provided, meeting minimal United States Nuclear Regulatory

Commission or its successor's requirements and the requirements established by the

State of New Jersey Bureau of Radiation Protection. The nuclear pharmacy shall be

separate from the pharmacy areas for non-radioactive drugs and shall be inaccessible to

all unauthorized personnel. All pharmacies handling radiopharmaceuticals shall be

provided with a radioactive storage and decay area. A nuclear pharmacy dispensing

radioactive drugs may be exempted from the general space requirements for

pharmacies.

c) The process used for handling radioactive materials by any license holder must involve

appropriate procedures for the purchase, receipt, storage, manipulation, compounding,

distribution, and disposal of radioactive materials. In order to ensure the public health,

safety, and welfare, a nuclear pharmacy shall first meet the following general

requirements:

The environment where the handling of radioactive materials takes place shall be

properly ventilated so that radioactive materials cannot be airborne from that

environment to other non-occupationally unrestricted areas;

The environment shall be properly located so that the receipt and dispersal of

radioactive materials does not result in inadvertent and undesired contamination of

other non-occupationally labeled areas;

The area shall be designed in such a manner that radioactive materials can be

contained in given areas to ensure adequate safety and protection to personnel

working in or near them and to insure proper operation of the corresponding assay

equipment; and

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Those engaged in the compounding of radiopharmaceuticals for injection shall

comply with N.J.A.C. 13:39-11, 11A, and 11B, as applicable.

d) Nuclear pharmacies shall maintain records of acquisition and disposition of all

radioactive drugs in accordance with rules and regulations of the United States Nuclear

Regulatory Commission.

e) The immediate outer container of a radioactive drug to be dispensed shall be labeled

with the following:

The standard radiation symbol;

The words, "CAUTION—RADIOACTIVE MATERIAL";

The radionuclide;

The chemical form;

The amount of radioactive material contained in millicuries or microcuries;

If a liquid, the volume in milliliters;

The requested calibration time for the radioactivity contained;

The name, address, and telephone number of the nuclear pharmacy;

The prescription number; and

10)

The date and patient's name, if available.

f) The immediate container shall be labeled with the following:

The standard radiation symbol;

The words, "CAUTION—RADIOACTIVE MATERIAL";

The name of the radiopharmaceutical.

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g) Nuclear pharmacies shall only dispense radiopharmaceuticals which comply with

acceptable professional standards of radiopharmaceutical quality assurance.

h) A nuclear pharmacist may transfer to authorized persons and United States Nuclear

Regulatory Commission licensed medical practitioners radioactive materials not intended

for drug use, in accordance with the regulations of the United States Nuclear Regulatory

Commission or its successor. A nuclear pharmacy may furnish radiopharmaceuticals to

these practitioners for patient use.

i) Nuclear pharmacies shall comply with all applicable laws and regulations of Federal and

State agencies including those laws and regulations governing non-radioactive drugs.

For nuclear pharmacies handling radiopharmaceuticals exclusively, the Board of

Pharmacy may waive rules pertaining to pharmacy permits for nonradiopharmaceuticals

which requirements do not pertain to the practice of nuclear pharmacy.

j) Radioactive drugs are to be dispensed only upon a non-refillable prescription order from

a United States Nuclear Regulatory Commission licensed medical practitioner (or the

designated agent) authorized to possess, use and administer radiopharmaceuticals.

k) Prescription orders for delivery of radioactive drugs for use in the medical practice of a

United States Nuclear Regulatory Commission licensed medical practitioner may be

placed on a telephone answering and recording device, only if the practitioner (or the

designated agent) is identified in such a manner that is clearly recognized by the nuclear

pharmacist dispensing the radioactive drug.

l) A qualified nuclear pharmacist shall have the authority to delegate to any qualified and

properly trained person or persons, acting under his or her immediate personal

supervision, any nuclear pharmacy act which a reasonable and prudent pharmacist

would find is within the scope of sound pharmaceutical judgment to delegate. Such

delegation may only occur if, in the professional opinion of the qualified nuclear

pharmacist, the act may be properly and safely performed by the person to whom the

pharmacy act is delegated. The delegated act may only be performed in its customary

manner, not in violation of other statutes. The person to whom a nuclear pharmacy act is

delegated shall not hold himself or herself out to the public as being authorized to

practice pharmacy.

13:39-12.3 GENERAL REQUIREMENTS FOR A NUCLEAR PHARMACIST

a) A qualified nuclear pharmacist shall meet the following requirements:

He or she is a pharmacist licensed to practice in the State of New Jersey; and

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He or she meets minimal standards of training and experience in the handling of

radioactive materials in accordance with the requirements of the United States

Nuclear Regulatory Commission or its successor and the State of New Jersey Bureau

of Radiation Protection.

13:39-12.4 MINIMUM REQUIREMENTS FOR SPACE, EQUIPMENT, SUPPLIES, AND

LIBRARY

a) Each nuclear pharmacy must meet the following requirements for space:

The area for the storage, compounding and dispensing of radioactive drugs shall be

completely separate from pharmacy areas for non-radioactive drugs;

Hot lab and storage area shall be a minimum of 120 square feet; and

The compounding and dispensing area shall be a minimum of 300 square feet.

b) Each nuclear pharmacy shall be equipped with at least the following items of equipment:

Dose calibrator;

Refrigerator;

Drawing station;

Well scintillation counter;

Microscope;

Chromatographic apparatus or comparable means of effectively assuring tagging

efficiency;

Radiation survey equipment of the appropriate type and calibration to detect

quantities of radioactive materials as prescribed in the appropriate radioactive

material licenses; and

Other equipment deemed necessary for radiopharmaceutical quality control for

products compounded or dispensed as may be determined by the United States

Nuclear Regulatory Commission or its successor and the State of New Jersey Bureau

of Radiation Protection.

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c) Each nuclear pharmacy shall have on the premises the following, up-to-date reference

books:

An up-to-date, comprehensive pharmaceutical reference text(s) and suitable

reference texts encompassing the general practice of pharmacy, drug interactions,

drug product composition and patient counseling. Unabridged computerized versions

of these reference texts shall be acceptable;

State statutes and rules relating to pharmacy;

State and Federal regulations governing the use of applicable radioactive materials;

and

Text relating to the practice of nuclear pharmacy and radiation safety.

13:39-12.5 QUALITY CONTROL

The holder of a nuclear pharmacy permit shall be responsible for the radioactive quality

control of all drugs, including biologicals, dispensed or manufactured. Radioactive

pharmaceutical quality controls include, but are not limited to, the carrying out and interpretation

of data resulting from chemical, biological and physical tests on potentially radioactive

pharmaceuticals to determine the suitability for use in humans and other animals, including

internal test assessment and authentication of product history.

SUBCHAPTER 13. COLLABORATIVE PRACTICE

13:39-13.1 PURPOSE AND SCOPE

The rules in this subchapter establish standards applicable to all pharmacists who seek

to engage in collaborative practice with one or more physicians licensed by the Board of Medical

Examiners. Only those activities that have been approved by the collaborating physician,

consistent with his or her scope of practice, shall be permitted.

13:39-13.2 DEFINITIONS

a) The following words and terms, as used in this subchapter, shall have the following

meanings, unless the context clearly indicates otherwise:

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“Collaborative drug therapy management" means the cooperative management of a

patient’s drug, biological, and device-related health care needs, pursuant to a collaborative

practice protocol directed on a voluntary basis by a patient’s physician with the patient’s

informed consent, by the patient’s physician and a pharmacist who has signed a collaborative

practice agreement with the physician.

“Collaborative practice” means that practice of pharmacy whereby one or more

pharmacists have jointly agreed to work in conjunction with one or more physicians for the

purpose of collaborative drug therapy management of patients, consistent with the requirements

of this subchapter.

“Collaborative practice protocol” means a written document that identifies the

collaborative drug therapy management actions that a pharmacist is authorized to perform for a

patient and that is developed jointly by the pharmacist and the physician and meets the

requirements outlined in N.J.A.C 13:39-13.5.

“Informed consent” means the written document that is signed by a patient whereby the

patient agrees to collaborative drug therapy management by the patient’s physician and a

pharmacist who has entered into a collaborative practice agreement with the physician.

“Therapeutic interchange” means the substitution and dispensing of a drug chemically

dissimilar from the prescription drug originally prescribed.

13:39-13.3 BOARD APPROVAL; PHARMACIST QUALIFICATIONS; CONTINUING

EDUCATION

a) In order to enter into an agreement to engage in the collaborative drug therapy

management of a patient with a physician licensed in this State, a licensed pharmacist

shall be pre-approved by the Board to engage in such activity. In order to obtain Board

approval, a pharmacist shall submit a collaborative practice application and

documentation that establishes that he or she has successfully completed one of the

following:

A certificate training program offered by an Accreditation Council for Pharmacy

Education (ACPE)-approved provider;

A post-graduate residency program accredited by the American Society of Health-

System Pharmacists; or

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A certification program from the Board of Pharmacy Specialties.

b) The Board shall issue an authorization to engage in collaborative drug therapy

management to a pharmacist who, upon application to the Board, demonstrates

satisfaction of the requirements of (a) above.

c) A pharmacist granted authorization to engage in collaborative drug therapy management

pursuant to this section shall complete a minimum of 10 credits of continuing education

every biennial renewal period in each disease(s) or condition(s) covered by the

collaborative practice agreement(s) to which he or she is a party, consistent with the

requirements of N.J.A.C. 13:39-3A. However, to the extent that a pharmacist may enter

into collaborative practice agreements to treat patients with co-existing, interrelated

conditions or diseases, a pharmacist need only complete a total of 10 credits in the

interrelated conditions or diseases.

13:39-13.4 COLLABORATIVE PRACTICE AGREEMENT

a) A pharmacist who engages in collaborative practice with one or more physicians shall

provide the Board, upon request, with a signed copy of a collaborative practice

agreement. The collaborative practice agreement shall be consistent with the example

contained in N.J.A.C. 13:39-13 Appendix, which is incorporated herein by reference. The

written agreement shall:

Identify, by name and title, each physician and each pharmacist who is permitted to

participate in a patient's collaborative drug therapy management, including all

covering physicians and/or pharmacists. Each covering physician shall meet the

requirements of N.J.A.C. 13:35-6.27(b) and each covering pharmacist shall meet the

requirements of N.J.A.C. 13:39-13.3. The agreement shall establish the means by

which the physician and/or pharmacist will be notified about covering practitioners for

collaborative practice purposes;

Specify the functions and responsibilities, including the scope of practice and

authority, to be exercised by the pharmacist;

Indicate any restrictions placed on the use of certain types or classes of drugs or

drug therapies;

Indicate any diagnosis or types of diseases that are specifically included or excluded;

Include copies of all protocols to be used in the collaborative practice;

Contain an effective date for the agreement; and

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Be signed and dated by the physician(s) and pharmacist(s).

b) Any changes, additions, or deletions to the collaborative practice agreement shall be

submitted to the Board upon request.

c) The pharmacist shall cooperate with the method established by the physician for

monitoring compliance with the agreement and clinical outcomes of the patients.

d) The collaborative practice agreement may be terminated at any time by either the

physician or the pharmacist by written documentation. Upon termination of a

collaborative practice agreement, the physician and the pharmacist shall provide notice

of the termination to each individual patient who is undergoing collaborative drug therapy

management. Upon termination of the agreement, the patient’s informed consent for

collaborative drug therapy management under the agreement shall be voided.

e) All records relating to a collaborative practice agreement shall be maintained in either

hard copy or electronic form for a period of not less than seven years from the date of

termination of the agreement and shall be supplied to the Board upon request. All

records shall be made available to persons authorized to inspect them under State and

Federal statutes and regulations. The oldest six years of information shall be maintained

in such a manner, so as to be retrievable and readable within two weeks. The most

recent one year of information shall be retrievable and readable within one business day.

Records not currently in use need not be stored in the pharmacy, but the storage

facilities shall be secure. Patient records shall be kept confidential.

13:39-13.5 COLLABORATIVE PRACTICE PROTOCOLS

a) A collaborative practice protocol shall be developed for each different type of

collaborative drug therapy management authorized by the physician under the

collaborative practice agreement and shall identify those activities that may be performed

by the collaborating pharmacist.

b) Each protocol shall:

Be jointly developed by the physician and the pharmacist, consistent with standards

and practices that are deemed commonly accepted and recognized by national

standard setting organizations, or national or State professional organizations of the

same discipline as the treating physician, and be signed and dated by both the

physician and the pharmacist;

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Be initiated and utilized at the sole discretion of the physician for a specific patient

with whom the physician has a bona fide physician-patient relationship as defined in

N.J.A.C. 13:35-6.27(a);

Be agreed to by both the physician and the pharmacist with the written informed

consent of the patient, consistent with the requirements of N.J.A.C. 13:39-13.6;

Be available at the practice sites of the pharmacist and physician and made available

at each site to the patient;

Establish the means by which the patient will be advised of the right to elect to

participate in and withdraw from the collaborative drug therapy management;

Establish when physician notification is required, the physician chart update interval,

and an appropriate time frame within which the pharmacist shall notify the physician

of any change in dose, duration, or frequency of medication prescribed. Written

notification, by either facsimile or electronic means, shall be provided to the physician

no later than eight hours after any change in prescribed medication is made by the

pharmacist;

Identify the method and time frame for notification of the physician if an adverse

event occurs; and

Be reviewed at least once per year by the parties to determine whether the protocol

should be renewed, modified, or terminated.

13:39-13.6 INFORMED CONSENT FOR COLLABORATIVE DRUG THERAPY

MANAGEMENT

a) Written informed consent shall be obtained from each individual patient participating in

collaborative drug therapy management. Both the physician and the pharmacist shall

retain a copy of the patient’s written informed consent. The written informed consent

shall:

Contain the specific patient’s name;

Identify the risks and benefits of collaborative drug therapy management, including

the fact that services provided under collaborative drug therapy management may not

be covered by the patient’s insurance provider;

Identify the fact that covering physicians and/or pharmacists may be utilized in the

collaborative drug therapy management of the patient’s care;

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Identify the patient’s right to elect to participate in and withdraw from the

collaborative drug therapy management; and

Be signed and dated by the patient.

13:39-13.7 SCOPE OF COLLABORATIVE DRUG THERAPY MANAGEMENT

a) Collaborative drug therapy management shall be between a single patient with whom the

physician has a bona fide physician-patient relationship, the physician, and the patient's

collaborative practice pharmacist(s) and shall address that patient's specific condition,

disease or diseases.

b) Collaborative drug therapy management may include the collecting, analyzing, and

monitoring of patient data, ordering or performing of laboratory tests based on the

standing orders of a physician as set forth in the written collaborative practice protocols,

consistent with (c) below; ordering of clinical tests based on the standing orders of a

physician as set forth in the written collaborative practice protocols; modifying,

continuing, or discontinuing drug or device therapy; and therapeutic drug monitoring with

appropriate modification to dose, dosage regimen, dosage forms, or route of

administration.

c) A pharmacist may perform laboratory tests that are granted waived status in accordance

with the provisions of the "New Jersey Clinical Laboratory Improvement Act," P.L. 1975,

c. 166 (N.J.S.A. 45:9-42.26 et seq.), Department of Health’s rules set forth at N.J.A.C.

8:44, and Department of Health CLIA Program requirements, available at

http://www.state.nj.us/health/phel/instruct116.shtml

, provided the tests are consistent

with the pharmacy practice area or disease state covered by the collaborative practice

agreement.

d) The interpretation of clinical or laboratory tests under a written collaborative practice

protocol shall be performed by a pharmacist only in direct consultation with a physician.

e) Collaborative drug therapy management shall not include therapeutic interchange at the

time of dispensing without the prior, specific informed consent of the patient and the

consent of the patient’s physician. Written confirmation of the consent, which may be by

electronic means, shall be maintained at the pharmacy practice site of the collaborating

pharmacist.

13:39-13.8 VOLUNTARY PARTICIPATION

a) Participation in, or withdrawal from, a collaborative practice agreement shall be voluntary

on the part of a physician and a pharmacist.

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b) Participation in, or withdrawal from, collaborative drug therapy management shall be

voluntary on the part of the individual patient.

13:39-13.9 FAILURE TO COMPLY

Any violation of the collaborative practice agreement or protocols on the part of the

pharmacist may be deemed professional misconduct and may subject the pharmacist to

discipline consistent with N.J.S.A. 45:1-21.

APPENDIX COLLABORATIVE PRACTICE AGREEMENT

The Pharmacist(s) and Physician(s) listed below are parties to this collaborative practice

agreement, through which the pharmacist(s) receives authority, under the supervision of the

physician(s) (or covering physician), to perform the functions outlined in accordance with

applicable New Jersey statutes and regulations.

Physician:

Name: _______________________________ Title: __________________________

Address: _____________________________________________________________

Phone Number: _____________________ License Number: ___________________

Type of Practice/Specialty: ________________________________________________

Pharmacist:

Name: _________________________________________________________________

Address: _______________________________________________________________

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Phone Number: _________________________ License Number: _________________

Qualifications for Collaborative Practice: _____________________________________

Describe the functions and responsibilities, including scope and authority, to be exercised by

the pharmacist (attach extra sheets if needed):

Indicate any restrictions placed on the use of certain types or classes of drugs or drug

therapies under this agreement (attach extra sheets if needed):

Indicate any diagnosis, or types of diseases which are specifically included or excluded

under this agreement (attach extra sheets if needed):

Attach any protocols to be used in decision making or other activities contemplated under

this agreement. This must include a protocol for treating an acute allergic or other adverse

reaction related to drug therapy. Each protocol must establish when physician notification is

required, the time frame within which the pharmacist must notify the physician of any change in

dose, duration or frequency of medication prescribed, and the type of pharmacist documentation

required. Written notification, by either facsimile or electronic means, shall be provided to the

physician no later than eight hours after any change in prescribed medication is made by the

pharmacist.

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Physician Signature: _____________________ Date: __________________

Pharmacist Signature: _____________________ Date: __________________

SUBCHAPTER 14. SELF-ADMINISTERED HORMONAL

CONTRACEPTIVES

13:39-14.1 PROTOCOL FOR PHARMACISTS FURNISHING SELF-ADMINISTERED

HORMONAL CONTRACEPTIVES

a) A pharmacist shall be authorized to furnish self-administered hormonal contraceptives to

a patient, in accordance with standardized procedures and protocols jointly developed

and approved by the Board and the State Board of Medical Examiners as set forth at

N.J.A.C. 13:39 Appendix A (Protocol), a standing order issued by a licensed physician

pursuant to the Protocol, and the rules in this chapter. If the licensed physician issuing

the standing order is the New Jersey Commissioner of the Department of Health, or a

designee, the standing order may have Statewide effect.

b) A pharmacist must keep a written copy of the Protocol and the standing order under

which the pharmacist furnishes hormonal contraceptives at each pharmacy practice site

at which the pharmacist furnishes self-administered hormonal contraceptives. The final

page of the Protocol must include the names of each pharmacist authorized pursuant to

this subchapter to furnish self-administered hormonal contraceptives at the pharmacy

practice site. The pharmacist must make a copy of the Protocol and the standing order

available upon the request of a representative of the Board.

c) Nothing in this subchapter or the Protocol shall be construed to expand the authority of a

pharmacist to prescribe any prescription medication.

d) The requirements of this subchapter and the Protocol do not apply to a pharmacist

dispensing a self-administered hormonal contraceptive pursuant to an individual

prescription issued by a healthcare practitioner authorized to prescribe self-administered

hormonal contraceptives in the course of professional practice or to a nonprescription

hormonal contraceptive; provided, however, that nothing in this subchapter shall prohibit

any person from obtaining a nonprescription hormonal contraceptive pursuant to the

Protocol.

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13:39-14.2 AUTHORIZATION OF PHARMACISTS TO FURNISH SELF-

ADMINISTERED HORMONAL CONTRACEPTIVES

a) In order for a pharmacist to be authorized to furnish self-administered hormonal

contraceptives pursuant to the Protocol, the pharmacist shall:

Complete a training program compliant with N.J.A.C. 13:39-14.7;

Affirm, in writing, that the pharmacist has completed a training program compliant

with N.J.A.C. 13:39-14.7, and will follow pertinent guidelines offered by the Federal

Centers for Disease Control and Prevention, including the United States Medical

Eligibility Criteria for Contraceptive Use. This written affirmation shall be retained by

the pharmacist and a copy shall be retained by the pharmacy as a medical record

pursuant to N.J.A.C. 13:39-14.6; and

Submit to the Board:

i) The pharmacist's written affirmation as required at (a)2 above; and

ii) A certificate of completion of the training course required pursuant to (a)1 above.

b) A pharmacist who is authorized to furnish a self-administered hormonal contraceptive

pursuant to the Protocol is prohibited from delegating the furnishing of hormonal

contraceptives to any other person. A pharmacy intern or pharmacy technician may

prepare the self-administered hormonal contraceptive for dispensing, but the steps at

N.J.A.C. 13:39-14.4 and 14.5(a) through (f) shall be completed by the pharmacist

authorized to furnish a hormonal contraceptive pursuant to the Protocol.

c) A pharmacist authorized to furnish hormonal contraception pursuant to this subchapter

shall comply with mandatory child abuse reporting obligations at N.J.S.A. 9:6-8.10,

including, but not limited to, reports of sexual offenses at N.J.S.A. 2C:14-1 et seq.

13:39-14.3 HORMONAL CONTRACEPTIVES AUTHORIZED PURSUANT TO THE

PROTOCOL

a) Pharmacists may furnish the following self-administered hormonal contraceptives

pursuant to the Protocol:

Combined oral contraceptive pill;

Progestin-only oral contraceptive pill;

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Patch;

Ring; and

Injectable hormonal contraceptive.

b) A pharmacist may not furnish any other self-administered hormonal contraceptives

pursuant to the Protocol. An injectable hormonal contraceptive furnished pursuant to the

Protocol must be self-administered by the patient and cannot be administered by the

pharmacist.

c) In the event the Federal Food and Drug Administration confers nonprescription status to

any contraceptive authorized to be furnished pursuant to the Protocol, a consumer shall

not be required to obtain that nonprescription contraceptive through the Protocol, but

may obtain it through the Protocol if the consumer chooses to do so.

13:39-14.4 PROCEDURES FOR HORMONAL CONTRACEPTIVE SCREENING AND

SELECTION

a) When an individual requests a pharmacist to furnish a self-administered hormonal

contraceptive, the pharmacist shall:

Have the patient complete the Health Screening Questionnaire prepared by the New

Jersey Department of Health. Upon request and whenever possible, the Health

Screening Questionnaire shall be provided in the recipient's primary spoken

language. If the patient does not complete the Health Screening Questionnaire, the

pharmacist shall not furnish a self-administered hormonal contraceptive pursuant to

the Protocol;

Review the Health Screening Questionnaire with the patient and clarify responses, if

needed;

Measure and record the patient's seated blood pressure, unless progestin-only oral

contraceptive pills are requested by the patient. Seated blood pressure may be

retaken if the first reading exceeds the level for eligibility according to the United

States Medical Eligibility Criteria for Contraceptive Use (USMEC) prepared by the

Federal Centers for Disease Control and Prevention (CDC). If the pharmacist uses a

device other than a stethoscope and manual blood pressure cuff to measure seated

blood pressure, the device shall be kept behind the pharmacy counter and be used

only by pharmacy staff; and

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Complete the Algorithm for Self-Administered Hormonal Contraceptive Pills, Patches,

and Rings set forth at N.J.A.C. 13:39-14 Appendix B or, if an injectable hormonal

contraceptive is under consideration, the Algorithm for Self-Administered Injectable

Hormonal Contraceptives set forth at N.J.A.C. 13:39-14 Appendix C. As part of that

process, the pharmacist must assess the health and history of the patient using the

latest version of the USMEC. Pharmacists may use the Summary Chart of the

USMEC, which is color-coded to match the Health Screening Questionnaire.

b) The pharmacist must provide patient privacy during health screening and counseling

consistent with the Federal Health Insurance Portability and Accountability Act, 45 CFR

Parts 160 and 164, Subparts A and E, and other applicable law.

c) The pharmacist must make clinical decisions that are free from any financial influence

imposed by insurance providers, contraceptive product manufacturers, and other parties

having a financial interest in the disbursement or non-disbursement of self-administered

hormonal contraceptives.

d) A pharmacist may furnish a self-administered hormonal contraceptive pursuant to the

Protocol only if the patient's intended use is contraception and only if the patient has

begun menstruating.

13:39-14.5 PROCEDURES FOR PATIENT COUNSELING AND FURNISHING

HORMONAL CONTRACEPTIVES

a) If the pharmacist concludes, based on N.J.A.C. 13:39-14.4, that a self-administered

hormonal contraceptive is indicated for the patient, the pharmacist may furnish one. The

pharmacist shall:

Ensure that the patient is appropriately instructed in the administration of the self-

administered hormonal contraceptive.

Provide the patient with counseling that includes the following information:

i) An information sheet for the product furnished that includes when and how to take

or use the hormonal contraceptive, when the contraceptive becomes effective,

what to do if the patient misses a dose or the contraceptive patch or ring

dislodges, possible side effects (including the risks, if any, of long-term use), and

when to seek medical attention;

ii) The package insert for the product furnished;

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iii) The importance of receiving recommended preventative health screenings and

following up with the patient's primary care provider or a medical clinic;

iv) That the self-administered hormonal contraceptive does not protect against

sexually transmitted infections or HIV, and that the use of a condom does provide

protection against sexually transmitted infections and HIV; and

v) Any other information relevant to the hormonal contraceptive furnished; if

medroxyprogesterone acetate is furnished, counsel the patient that using it for

more than two years is not recommended because of a risk of loss of significant

bone mineral density.

Provide the patient with a written record of the self-administered hormonal

contraceptive furnished. The pharmacist may use the Pharmacist Visit Summary and

Referral template set forth at N.J.A.C. 13:39-14 Appendix D and available at

https://www.njconsumeraffairs.gov/phar/Pages/default.aspx to provide the written

record and may customize the template by adding to it, but may not remove any

elements from the template. At a minimum, the written record provided by the

pharmacist to the patient must include:

i) The patient's name and date of birth;

ii) The name, address, permit number, and telephone number of the pharmacy

practice site, and the name, license number, and signature of the pharmacist;

iii) The date of the visit and the date on which the self-administered hormonal

contraceptive was furnished;

iv) The name and strength (if applicable) of the contraceptive that was furnished;

v) The quantity furnished and how many refills were authorized (if any);

vi) Any recommended follow-up; and

vii) A statement that information on reproductive rights, health care coverage and

services, and other resources can be found at the New Jersey Reproductive

Health Information Hub, https://www.nj.gov/health/reproductivehealth/.

Offer to provide counseling to the patient about other forms of contraception,

including contraception not included at N.J.A.C. 13:39-14.3(a), that have been

approved by the Federal Food and Drug Administration, and, if the patient accepts

the offer for counseling, the pharmacist must provide the patient with specific and

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appropriate information about such other forms of contraception, based on the results

of the Health Screening Questionnaire.

At each patient encounter, provide the patient with a referral to the patient's primary

care provider, or, if the patient does not have a primary care provider, to an

appropriate and nearby medical clinic that provides primary and contraceptive care.

The Pharmacist Visit Summary and Referral template set forth at N.J.A.C. 13:39-14

Appendix D and available at

https://www.njconsumeraffairs.gov/phar/Pages/default.aspx may be used. A

pharmacist may customize the template by adding to it, but may not remove any

elements from the template.

b) If the patient is eligible to receive a self-administered hormonal contraceptive from the

pharmacist, the pharmacist may furnish an initial supply of up to three months at one

time, with a refill for up to nine months, for a total of 12 months.

c) At three months, the pharmacist shall recheck the patient's blood pressure and ask if

there are any changes to the patient's responses to the Health Screening Questionnaire

to verify the patient's continued eligibility for the hormonal contraceptive, provided that

measuring seated blood pressure is not necessary if the patient is taking progestin-only

oral contraceptive pills.

d) If, after 12 months, the patient requests a refill, the pharmacist shall repeat the

procedures at N.J.A.C. 13:39-14.4. The patient shall complete the Health Screening

Questionnaire at least once every 12 months.

If there is no change in the formulation or method of contraceptive furnished to the

patient, the pharmacist may authorize refills for a supply of up to 12 months.

If there is a change in the formulation or method of hormonal contraceptive furnished

to the patient, then the pharmacist may furnish an initial supply of up to three months

at one time, with refills for up to nine months, for a total of 12 months. At three

months, the pharmacist shall recheck the patient's blood pressure and ask if there

are any changes to the patient's responses to the Health Screening Questionnaire,

provided that rechecking seated blood pressure is not necessary if the patient is

taking progestin-only oral contraceptive pills.

e) A pharmacist shall not continue to furnish medroxyprogesterone acetate after two years

without a prescription from a health care provider. If a patient has used

medroxyprogesterone acetate for one year and nine months, the pharmacist shall refer

the patient to a health care provider to obtain a prescription.

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f) If the evaluation indicates that hormonal contraceptives are contraindicated for the

patient, the pharmacist shall not furnish one.

The pharmacist shall offer to provide counseling to the patient about other forms of

contraception, including contraception not included at N.J.A.C. 13:39-14.3(a), that

have been approved by the Federal Food and Drug Administration, and, if the patient

accepts the offer for counseling, the pharmacist must provide the patient with specific

and appropriate information about such other forms of contraception, based on the

results of the Health Screening Questionnaire.

The pharmacist must provide the patient with a referral to the patient's primary care

provider, or, if the patient does not have a primary care provider, to an appropriate

and nearby medical clinic that provides primary and contraceptive care. The

Pharmacist Visit Summary and Referral template set forth at N.J.A.C. 13:39-14

Appendix D and available at

https://www.njconsumeraffairs.gov/phar/Pages/default.aspx may be used. A

pharmacist may customize the template by adding to it, but may not remove any

elements from the template. The referral must include the reason the pharmacist did

not furnish a self-administered hormonal contraceptive to the patient.

g) The dispensing of the self-administered hormonal contraceptive furnished pursuant to a

standing order shall be processed in the same manner that a prescription drug or device

is dispensed, pursuant to the applicable statutes and rules for the dispensing of

prescription drugs and devices. When furnishing self-administered hormonal

contraceptives pursuant to the Protocol, the name and National Provider Identifier

number of the licensed physician issuing the standing order is entered in the patient

profile as the prescriber.

13:39-14.6 RECORDKEEPING

a) The pharmacist must keep the following records:

A written or electronic record for any patient screened and for any self-administered

hormonal contraceptive that is furnished pursuant to the Protocol, including, without

limitation, any completed Health Screening Questionnaire, Pharmacist Visit Summary

and Referral form, and all of the information required at N.J.A.C. 13:39-7.6; and

Documentation of the pharmacist's successful completion of the self-administered

hormonal contraceptive training program, the affirmation required at N.J.A.C. 13:39-

14.2(a) and a copy of the Protocol with the names of pharmacists who may furnish

self-administered hormonal contraceptives pursuant to the standing order at the

pharmacy practice site, as required at N.J.A.C. 13:39-14.2(b).

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b) All records required pursuant to the Protocol shall be maintained in either hard copy or

electronic form for a period of not less than seven years and shall be supplied to the

Board upon request.

c) All records shall be made available to persons authorized to inspect them pursuant to

State and Federal statutes and regulations. The oldest six years of information shall be

maintained in such a manner, so as to be retrievable and readable within two weeks. The

most recent one year of information shall be retrievable and readable within one

business day.

d) Records not currently in use need not be stored in the pharmacy, but the storage

facilities shall be secure.

e) Patient records shall be kept confidential.

13:39-14.7 HORMONAL CONTRACEPTIVE TRAINING

a) In order to be authorized to furnish self-administered hormonal contraceptives pursuant

to the Protocol, a pharmacist must successfully complete a training program recognized

pursuant to (c) below that is at least four credits and trains the pharmacist to:

Screen patients to determine eligibility for the self-administered hormonal

contraceptives authorized at N.J.A.C. 13:39-14.3;

Select a self-administered hormonal contraceptive; and

Counsel patients.

b) A training program that provides education only on the pharmacology of contraceptives is

not sufficient to satisfy the requirements of this section.

c) The Board shall recognize training programs that meet the requirements at (a) above and

are:

Offered at a college of pharmacy accredited by the Accreditation Council for

Pharmacy Education;

Offered by an Accreditation Council for Pharmacy Education-approved provider; and

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Of comparable scope and rigor to courses accredited by the Accreditation Council for

Pharmacy Education and be approved by the Board pursuant to N.J.A.C. 13:39-3A.6

and by the State Board of Medical Examiners.

APPENDIX A PHARMACIST HORMONAL CONTRACEPTIVES

PROTOCOL

Background

On January 13, 2023, Governor Phil Murphy signed into law P.L. 2023, c. 2 (codified at

N.J.S.A. 45:14-67.9), which states:

"Notwithstanding any other law to the contrary, a pharmacist shall be authorized to furnish

self-administered hormonal contraceptives to a patient, in accordance with standardized

procedures and protocols to be jointly developed and approved by the Board of Pharmacy

and the State Board of Medical Examiners, in consultation with the American Congress of

Obstetricians and Gynecologists, the New Jersey Pharmacists Association, and other

appropriate entities, and in accordance with the 'Administrative Procedure Act,' P.L.1968,

c.410 (C.52:14B-1 et seq.) and the provisions of this subsection."

This protocol ("Protocol") was developed jointly by the State Board of Medical Examiners

and the Board of Pharmacy after consulting with professional associations and other appropriate

entities. It was approved by the State Board of Medical Examiners on April 10, 2024 and by the

Board of Pharmacy on April 24, 2024.

Pursuant to this Protocol, the Commissioner of the New Jersey Department of Health (or the

Commissioner's designee) issued a statewide standing order authorizing New Jersey licensed

pharmacists to furnish self-administered hormonal contraceptives to patients without an

individual prescription. The State Board of Medical Examiners regulations implementing the

Protocol are found at N.J.A.C. 13:35-6.28. The Board of Pharmacy regulations implementing the

Protocol are found at N.J.A.C. 13:39-14.1 through 14.7.

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A pharmacist who furnishes self-administered hormonal contraceptives pursuant to a

standing order must follow this Protocol and the regulations of the Board of Pharmacy. Copies of

all documents and templates referenced in this Protocol are available on the Board of

Pharmacy's website at https://www.njconsumeraffairs.gov/phar/Pages/default.aspx.

Pharmacist Authorization

In order for a pharmacist to be authorized to furnish self-administered hormonal

contraceptives pursuant to this Protocol, the pharmacist shall:

1. Complete a training program compliant with N.J.A.C. 13:39-14.7;

2. Affirm, in writing, that the pharmacist has completed a training program compliant with

N.J.A.C. 13:39-14.7 and will follow pertinent guidelines offered by the Federal Centers for

Disease Control and Prevention, including the United States Medical Eligibility Criteria for

Contraceptive Use. This written affirmation shall be retained by the pharmacist and a copy shall

be retained by the pharmacy as a medical record pursuant to N.J.A.C. 13:39-14.6; and

3. Submit to the Board:

i. The pharmacist's written affirmation from 2 above; and

ii. A certificate of completion of the training course required by 1 above.

A pharmacist must keep a written copy of this Protocol and the standing order under which

the pharmacist furnishes hormonal contraceptives at each pharmacy practice site at which the

pharmacist furnishes self-administered hormonal contraceptives. This Protocol must include the

names of each pharmacist authorized pursuant to N.J.A.C. 13:39-14 to furnish self-administered

hormonal contraceptives at the pharmacy practice site on the final page. The pharmacist must

make a copy of the Protocol and the standing order available upon the request of a

representative of the Board of Pharmacy.

A pharmacist who is authorized to furnish a self-administered hormonal contraceptive

pursuant to this protocol is prohibited from delegating the furnishing of hormonal contraceptives

to any other person. A pharmacy intern or pharmacy technician may prepare the self-

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administered hormonal contraceptive for dispensing, but the steps at N.J.A.C. 13:39-14.4 and

14.5(a) through (f) must be completed by the pharmacist authorized to furnish a hormonal

contraceptive pursuant to this Protocol.

A pharmacist authorized to furnish hormonal contraceptives pursuant to this subchapter shall

comply with mandatory child abuse reporting obligations at N.J.S.A. 9:6-8.10, including but not

limited to, reports of sexual offenses at N.J.S.A. 2C:14-1 et seq.

Hormonal Contraceptives Authorized Pursuant to this Protocol

Pharmacists may furnish the following self-administered hormonal contraceptives pursuant to

this Protocol:

1. Combined oral contraceptive pill;

2. Progestin-only oral contraceptive pill;

3. Patch;

4. Ring; and

5. Injectable hormonal contraceptive.

A pharmacist may not furnish any other self-administered hormonal contraceptives pursuant

to the Protocol. An injectable hormonal contraceptive furnished pursuant to the Protocol must be

self-administered and cannot be administered by the pharmacist.

Procedures for Hormonal Contraceptive Screening and Selection

(a) When an individual requests a pharmacist to furnish a self-administered hormonal

contraceptive, the pharmacist shall:

1. Have the patient complete the Health Screening Questionnaire prepared by the New

Jersey Department of Health. Upon request and whenever possible, the Health Screening

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Questionnaire shall be provided in the recipient's primary spoken language. If the patient does

not complete the Health Screening Questionnaire, the pharmacist shall not furnish a self-

administered hormonal contraceptive pursuant to the Protocol;

2. Review the Health Screening Questionnaire with the patient and clarify responses, if

needed;

3. Measure and record the patient's seated blood pressure, unless progestin-only oral

contraceptive pills are requested by the patient. Seated blood pressure may be retaken if the

first reading exceeds the level for eligibility according to the United States Medical Eligibility

Criteria for Contraceptive Use (USMEC) prepared by the Federal Centers for Disease Control

and Prevention (CDC). If the pharmacist uses a device other than a stethoscope and manual

blood pressure cuff to take seated blood pressure, the device shall be kept behind the pharmacy

counter and be used only by pharmacy staff; and

4. Complete the Algorithm for Self-Administered Hormonal Contraceptive Pills, Patches, and

Rings or, if an injectable hormonal contraceptive is under consideration, the Algorithm for Self-

administered Injectable Hormonal Contraceptives. As part of that process, the pharmacist must

assess the health and history of the patient using the latest version of the USMEC. Pharmacists

may use the Summary Chart of the USMEC, which is color-coded to match the Health Screening

Questionnaire.

(b) The pharmacist must provide patient privacy during health screening and counseling

consistent with the Federal Health Insurance Portability and Accountability Act, 45 C.F.R. Part

160 and Subparts A and E of Part 164, as may be amended and supplemented, and other

applicable law.

Protocol only if the patient's intended use is contraception and only if the patient has begun

menstruating.

Procedures for Patient Counseling and Furnishing Hormonal Contraceptives

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(a) If the pharmacist concludes based on "Procedures for Hormonal Contraceptive Screening

and Selection" above that a self-administered hormonal contraceptive is indicated for the patient,

the pharmacist may furnish one. The pharmacist shall:

1. Ensure that the patient is appropriately instructed in the administration of the self-

administered hormonal contraceptive.

2. Provide the patient with appropriate counseling and the following information:

i. An information sheet for the product furnished that includes, without limitation, when and

how to take or use the hormonal contraceptive, when the contraceptive becomes effective, what

to do if the patient misses a dose or the contraceptive patch or ring dislodges, possible side

effects (including the risks, if any, of long term use), and when to seek medical attention;

ii. The package insert for the product furnished;

iii. The importance of receiving recommended preventative health screenings and following

up with the patient's primary care provider or a medical clinic;

iv. That the self-administered hormonal contraceptive does not protect against sexually

transmitted infections or HIV, and that the use of a condom does provide protection against

sexually transmitted infections and HIV; and

v. Any other information relevant to the hormonal contraceptive furnished; if

medroxyprogesterone acetate is furnished, counsel the patient that using it for more than two

years is not recommended because of a risk of loss of significant bone mineral density.

3. Provide the patient with a written record of the self-administered hormonal contraceptive

furnished. The pharmacist may use the Pharmacist Visit Summary and Referral template

available at https://www.njconsumeraffairs.gov/phar/Pages/default.aspx to provide the written

record and may customize the template by adding to it, but may not remove any elements from

the template. At a minimum, the written record provided by the pharmacist to the patient must

include:

i. The patient's name and date of birth;

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ii. The name, address, permit number, and telephone number of the pharmacy practice site,

and the name, license number, and signature of the pharmacist;

iii. The date of the visit and the date on which the self-administered hormonal contraceptive

was furnished;

iv. The name and strength (if applicable) of the contraceptive that was furnished;

v. The quantity furnished and how many refills were authorized (if any);

vi. Any recommended follow-up; and

vii. A statement that information on reproductive rights, health care coverage and services,

and other resources can be found at the New Jersey Reproductive Health Information Hub,

https://www.nj.gov/health/reproductivehealth/.

4. Offer to provide counseling to the patient about other forms of contraception, including

contraception not included in "Hormonal Contraceptives Authorized Pursuant to this Protocol"

above, that have been approved by the Federal Food and Drug Administration, and, if the

patient accepts the offer for counseling, the pharmacist must provide the patient with specific

and appropriate information about such other forms of contraception, based on the results of the

Health Screening Questionnaire.

5. At each patient encounter, provide the patient with a referral to the patient's primary care

provider, or, if the patient does not have a primary care provider, to an appropriate and nearby

medical clinic that provides primary and contraceptive care. The Pharmacist Visit Summary and

Referral template available at https://www.njconsumeraffairs.gov/phar/Pages/default.aspx may

be used. A pharmacist may customize the template by adding to it, but may not remove any

elements from the template.

(b) If the patient is eligible to receive a self-administered hormonal contraceptive from the

pharmacist, the pharmacist may furnish an initial supply of up to three months at one time, with

refills for up to nine months, for a total of twelve months.

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there are any changes to the patient's responses to the Health Screening Questionnaire,

provided that measuring seated blood pressure is not necessary if the patient is taking

progestin-only oral contraceptive pills.

(d) If, after twelve months, the patient requests a refill, the pharmacist shall repeat the

procedures in "Procedures for Hormonal Contraceptive Screening and Selection" above. The

patient shall complete the Health Screening Questionnaire at least once every twelve months.

1. If there is no change in the formulation or method of contraceptive furnished to the patient,

the pharmacist may authorize refills for a supply of up to twelve months.

2. If there is a change in the formulation or method of hormonal contraceptive furnished to

the patient, then the pharmacist may furnish an initial supply of up to three months at one time,

with refills for up to nine months, for a total of twelve months. At three months, the pharmacist

shall recheck the patient's blood pressure and ask if there are any changes to the patient's

responses to the Health Screening Questionnaire, provided that rechecking seated blood

pressure is not necessary if the patient is taking progestin-only oral contraceptive pills.

(e) A pharmacist shall not continue to furnish medroxyprogesterone acetate after two years

without a prescription from a healthcare provider. If a patient has used medroxyprogesterone

acetate for one year and nine months, the pharmacist shall refer the patient to a health care

provider to obtain a prescription.

(f) If the evaluation indicates that hormonal contraceptives are contraindicated for the

patient, the pharmacist must not furnish one.

1. The pharmacist must offer to provide counseling to the patient about other forms of

contraception, including contraception not included in "Hormonal Contraceptives Authorized

Pursuant to this Protocol" above, that have been approved by the Federal Food and Drug

Administration, and, if the patient accepts the offer for counseling, the pharmacist must provide

the patient with specific and appropriate information about such other forms of contraception,

based on the results of the Health Screening Questionnaire.

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2. The pharmacist must provide the patient with a referral to the patient's primary care

provider, or, if the patient does not have a primary care provider, to an appropriate and nearby

medical clinic that provides primary and contraceptive care. The Pharmacist Visit Summary and

Referral template available at https://www.njconsumeraffairs.gov/phar/Pages/default.aspx may

be used. A pharmacist may customize the template by adding to it, but may not remove any

elements from the template. The referral must include the reason the pharmacist did not furnish

a self-administered hormonal contraceptive to the patient.

(g) The dispensing of the self-administered hormonal contraceptive furnished pursuant to a

standing order shall be processed in the same manner that a prescription drug or device is

dispensed, pursuant to the applicable statutes and rules for the dispensing of prescription drugs

and devices. When furnishing self-administered hormonal contraceptives per this Protocol, the

name and National Provider Identifier number of the physician issuing the standing order is

entered in the patient profile as the prescriber.

Recordkeeping

The pharmacist must keep the following records for seven years according to the

requirements at N.J.A.C. 13:39-14.6(b) through (e):

1. A written or electronic record for any patient screened and for any self-administered

hormonal contraceptive that is furnished under the Protocol, including, without limitation, any

completed Health Screening Questionnaire, Pharmacist Visit Summary and Referral form, and

all of the information required at N.J.A.C. 13:39-7.6; and

2. Documentation of the pharmacist's successful completion of the self-administered

hormonal contraceptive training program, the affirmation required at N.J.A.C. 13:39-14.2(a) and

a copy of the Protocol with the names of pharmacists who may furnish self-administered

hormonal contraceptives under the standing order at the pharmacy practice site as required at

N.J.A.C. 13:39-14.2(b).

Pharmacists Authorized to Furnish Self-Administered Hormonal Contraceptives

Pharmacy Name: _________________________________

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Pharmacy Practice Site Address: _____________________

Pharmacy Permit Number: _________________________

Pharmacy Phone Number __________________________

By signing below, the pharmacist affirms that the pharmacist has completed a training

program compliant with N.J.A.C. 13:39-14.7, will follow pertinent guidelines offered by the

Federal Centers for Disease Control and Prevention, including the United States Medical

Eligibility Criteria for Contraceptive Use, and is authorized to furnish self-administered hormonal

contraceptives pursuant to the New Jersey Pharmacist Hormonal Contraceptives Protocol. This

form will be retained as a medical record for seven years.

Name Signature

1) ______________________ _____________________

2) ______________________ _____________________

3) ______________________ _____________________

4) ______________________ _____________________

5) ______________________ _____________________

6) ______________________ _____________________

7) ______________________ _____________________

8) ______________________ _____________________

9) ______________________ _____________________

10) _____________________ _____________________

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APPENDIX B ALGORITHM FOR SELF-ADMINISTERED HORMONAL

CONTRACEPTIVE PILLS, PATCHES, AND RINGS

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APPENDIX C ALGORITHM FOR SELF-ADMINISTERED INJECTABLE

HORMONAL CONTRACEPTIVES

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APPENDIX D PHARMACIST VISIT SUMMARY AND REFERRAL

TEMPLATE

Attention: You may customize this template by adding to it; however, you must retain all

elements in this template.

Patient Name:________________ Date of birth:____/____/________

Date of visit: ___/___/___

Date hormonal contraceptive furnished (if applicable): ___/___/____

Please review this form with your primary care provider. If you do not have a primary care

provider, you may follow up at _____________________ (insert name, address, and phone

number of an appropriate and nearby medical clinic that provides primary and contraceptive

care).

Recommended follow-up: ____________________________________________________

Self-administered hormonal contraceptive furnished: ________________________________

Strength (if applicable): _____________________ Quantity furnished: ______________

Refills authorized: ______________

______ Pharmacist is not able to furnish a self-administered hormonal contraceptive to you

because:

[ ] Pregnancy cannot be ruled out.

[ ] You may have a health condition than requires further evaluation.

[ ] You take medication(s) or supplements that may interfere with contraceptives.

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[ ] Your blood pressure reading is _______/_____ (140/90 or higher) and you are not eligible

for progestin-only pills because ______________________________________.

[ ] Other (e.g., intended use is not contraception)

Notes:_____________________________________________________________

Each requires additional evaluation by another healthcare provider. Please share this

information with your provider.

Pharmacist Name ___________________________________________________________

Pharmacist Signature _______________________________________________________

Pharmacist License Number ___________________________________________________

Pharmacy Name ____________________________________________________________

Pharmacy Practice Site Permit Number __________________________________________

Pharmacy Practice Site Address ________________________________________________

Pharmacy Practice Site Phone Number __________________________________________

Information on reproductive rights, health care coverage and services, and other resources

can be found at the New Jersey Reproductive Health Information Hub,

https://www.nj.gov/health/reproductivehealth/.